Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
Conditions: Meniscus Tear, Retention; Meniscus
Sponsor: Smith & Nephew, Inc.

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 1 of 94 
Sponsor Name and 
Address: 
Smith + Nephew, Inc. 
7135 Goodlett Farms Parkway 
Cordova, TN 38016 
Investigational Product(s) 
NOVOSTITCH PRO™ Meniscal Repair System 
Protocol Author(s): 
Kirsten Wall, MHS, CCRP, PMP 
Clinical Study Manager 
Smith + Nephew, Inc. 
Darvin Griffin, PhD 
Global Clinical Strategy Lead 
Smith + Nephew, Inc. 
Michelle Foster, BSc 
Senior Biostatistician 
Smith + Nephew, Inc. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 2 of 94 
 
SIGNATURES 
 
1.1 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
This page will be returned to Smith + Nephew, Inc. and a copy retained at the investigational 
site. 
 
 
 
 
Name, Address, 
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
I have read the attached protocol entitled “Circumferential Compression STITCH Repairs of 
Complex and Horizontal Cleavage Meniscal Tears”, version 2.0, dated 07/APR/2020, and 
agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in Section 21.5 of the protocol, 
I agree to ensure that the confidential information contained in this document will not be used 
for any purpose other than the conduct of the described clinical investigation without the prior 
written consent of Smith + Nephew, Inc. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 3 of 94 
I have read the attached protocol entitled “Circumferential Compression STITCH Repairs of 
Complex and Horizontal Cleavage Meniscal Tears”, version 2.0, dated 07/APR/2020, and 
agree to abide by all provisions set forth therein. 
 
1.2 
COORDINATING INVESTIGATOR APPROVAL 
 
 
 
 
Name, Address, 
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 4 of 94 
 
1.3 
SPONSOR APPROVAL 
 
Job title 
DocuSign Stamp 
Rachael Winter, 
Global Clinical 
Operations 
Director of Clinical 
Operations 
 
Stephan Mangin, 
Global Clinical Strategy 
Director of GCS Sports 
Medicine and ENT 
 
Alan Rossington, 
Global Biostatistics 
Director of Biostatistics 
 
Luca Orlandini, 
Medical Affairs 
Vice President of 
Global Medical Affairs 
 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 5 of 94 
 
SYNOPSIS 
 
Title of Study: 
Circumferential Compression STITCH Repairs of Complex and 
Horizontal Cleavage Meniscal Tears 
Study Design: 
Prospective, multi-center, non-randomized clinical trial 
• 
90 subjects total at up to 8 sites 
o 2 groups: 
 
At least 40 subjects with horizontal cleavage 
meniscal tears (HCT) 
 
At least 40 subjects with complex meniscal 
tears 
• 
Follow-up: 2 years 
Study Type: 
Observational, prospective clinical follow-up study 
Study Product: 
NOVOSTITCH PRO™ Meniscal Repair System (NOVOSTITCH 
PRO) 
NOVOSTITCH PRO is intended for approximation of soft tissue in 
meniscal repair procedures. 
Study Purpose: 
The purpose of this study is to collect safety and clinical outcomes 
data from patients who underwent meniscal repair with the 
NOVOSTITCH PRO Meniscal Repair System. 
Primary Objective: 
The primary objective of this study is to assess the clinical success 
rate of NOVOSTITCH PRO at 12 months, defined as rate of 
freedom from reoperation due to meniscal repair failure in the study 
knee. 
Secondary 
Objective(s): 
The secondary objectives are to: 
• 
Assess the clinical success rate of NOVOSTITCH PRO at 6 
months, defined as rate of freedom from reoperation due to 
meniscal repair failure in the study knee; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 6 of 94 
 
• 
Assess the clinical success rate of NOVOSTITCH PRO at 24 
months, defined as rate of freedom from reoperation due to 
meniscal repair failure in the study knee; 
• 
Assess clinical performance of NOVOSTITCH PRO by 
Patient Reported Outcomes (PROs) including the Knee 
Injury and Osteoarthritis Outcome Score (KOOS), 
International Knee and Documentation Committee (IKDC) 
Subjective, and Lysholm; 
• 
Evaluate pre- and post-procedure magnetic resonance 
imaging (MRI) and radiographs, and post-procedure needle 
endoscopy. 
Safety Objective(s): 
Assess safety with reported complications, adverse events, adverse 
device effects, unanticipated serious adverse device effects, and 
device deficiencies. 
Sample Size: 
90 subjects 
With an estimated clinical success rate of 80% at 12 months for the 
planned study, the 95% confidence interval for clinical success was 
calculated between 70% and 90%. Using an 84% success rate, the 
minimum enrollment is N=71. With an attrition rate of 10% per year, 
total enrollment is set to N=90. 
Number of Study Sites: 
Up to 8 sites, with a minimum of 3 sites 
Targeted Global 
Regions: 
United States (US) 
Inclusion Criteria: 
The subject will be eligible for the study if he or she meets all of the 
baseline screening and arthroscopy inclusion criteria. 
Subjects will be eligible for the study if they meet all of the following 
criteria at the Baseline Screening: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 7 of 94 
 
1. Able and willing to give informed consent by voluntarily 
providing written informed consent in accordance with 
governing Institutional Review Board; 
2. 18 to 70 years of age, inclusive at the time of screening; 
3. History indicative of meniscal pathology (e.g., pain, 
mechanical symptoms described as locking, clicking or 
giving way); 
4. Physical exam consistent with meniscus tear (e.g., locked 
joint, joint line tenderness and/or pain on meniscal 
compression); 
5. If prior ligament reconstruction, the study knee is clinically 
stable; 
6. Meniscal repair to be performed arthroscopically; 
7. Preoperative MRI evidence consistent with a horizontal 
cleavage or complex meniscus tear in the symptomatic 
compartment; 
8. Willing and able to comply with all study procedures and visit 
requirements, including MRIs, X-rays, and Case Report 
Forms (CRFs) completed by the subject. 
Consented subjects may be included in the study only if, upon 
arthroscopic inspection during the procedure, their meniscal study 
lesion meets all of the following criteria: 
1. Meniscal tear amenable to repair with NOVOSTITCH 
PRO with or without the use of adjunct devices per 
the exclusion criteria; 
2. Tear pattern is one of the following: 
a. Horizontal cleavage tear (HCT), or 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 8 of 94 
 
b. Complex multi-planar tear (combination of at 
least two of the following tears: horizontal, 
oblique, radial, vertical). 
Exclusion Criteria: 
The subject will be ineligible for the study is he or she meets any of 
the following exclusion criteria at the baseline screening or at 
arthroscopy. 
Subjects will be excluded from the study if they meet any of 
following criteria at the Baseline Screening: 
1. Arthritis in the study knee (Kellgren-Lawrence Grade 3 or 
higher); 
2. Body Mass Index (BMI) ≥40 kg/m2; 
3. Previous surgical meniscal repair or meniscectomy of the 
study meniscus; 
4. Unstable knee; 
5. Clinically significant malalignment of the study knee, and/or 
requiring osteotomy, and/or correction; 
6. History of constitutional/systemic inflammatory/arthritic 
problem or pain condition, history of knee infection, vascular 
condition of legs, benign neoplasms of knee, hepatitis, 
and/or HIV; 
7. Currently on any immunosuppressive therapy; 
8. Expected to undergo any other surgical treatment of either 
knee; 
9. Previously enrolled in the study (no bilateral knee surgeries); 
10. Surgical procedures other than those listed in the Indications 
for Use; 
11. Patient conditions including insufficient quantity or quality of 
tissue; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 9 of 94 
 
12. Insufficient blood supply or previous infections which may 
hinder the healing process; 
13. Foreign body sensitivity. If material sensitivity is suspected, 
testing should be completed prior to suture implantation; 
14. Conditions which may limit the patient’s ability or willingness 
to follow postoperative care instructions; 
15. Any concomitant painful or disabling disease, condition or 
post-procedure status of either lower extremity that would 
interfere with evaluation or rehabilitation of the study knee; 
16. Pregnant or planning to become pregnant in the next 2 
years; 
17. Subject does not understand a language in which the PROs 
and EQ-5D-5L are available. 
Subjects will be excluded from the study if their study meniscus 
lesion meets any of the following criteria at arthroscopy: 
1. Ramp tears; 
2. Root or other tear type requiring tibial fixation; 
3. Tears requiring repair of both meniscus in the study 
knee; 
4. Intact or partially intact meniscus tear that, in the opinion 
of the Investigator, does not require repair; 
5. Poor meniscal tissue quality such that it will not hold a 
suture; 
6. For HCTs: 
a. Use of any capsular fixation device; OR 
b. Any portion of the meniscal tear is repaired using 
a device to place stitches other than 
NOVOSTITCH PRO, Meniscus Mender II, or 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 10 of 94 
 
Meniscal Stitcher, or FIRSTPASS MINI marketed 
by Smith + Nephew Inc.; 
7. For complex tears: 
a. Any portion of the meniscal tear is repaired using 
a device to place stitches other than 
NOVOSTITCH PRO, Meniscus Mender II, 
Meniscal Stitcher, FIRSTPASS MINI, FAST-FIX 
360, or ULTRA FAST-FIX marketed by Smith + 
Nephew Inc.; 
8. Clinically significant (zone 1 and/or zone 2) tear in the 
contralateral compartment to the study meniscus; 
9. Performance of a significant concomitant procedure (e.g. 
ACL reconstruction or repair, cartilage repair or 
restoration) intended as a therapeutic intervention on the 
study knee; 
10. Presence of infection; 
11. Articular cartilage damage in the study knee, defined as 
Modified Outerbridge Grade III or higher. 
Study Duration: 
Estimated to be 42 months (16 months for subject enrollment + 26 
months for completion of follow-up) 
Primary Endpoint: 
Rate of reoperation due to meniscal repair failure at 12 months post- 
operative. 
Secondary 
Endpoint(s): 
• 
Rate of reoperation due to meniscal repair failure at 6 and 24 
months post-operative; 
• 
MRI of structural integrity of meniscus at baseline, 12 
months and 24 months; 
• 
Radiographs to evaluate tibiofemoral joint space narrowing 
(JSN) at baseline and 24 months; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 11 of 94 
 
• 
Results of in-office needle endoscopy at 6 months, if 
available; 
• 
Patient Reported Outcomes (PRO) data will be collected on 
International Knee Documentation Committee (IKDC) 
Subjective, Knee Injury and Osteoarthritis Outcome Score 
(KOOS) and Lysholm score for baseline and 6, 12 and 24 
month follow-up time points. 
Safety Endpoint(s): 
• 
Device-related re-intervention; 
• 
All adverse events (AEs) occurring from the time of surgery 
until revision or study completion; 
• 
Device related AEs (ADEs) and serious adverse events 
(SAE’s); 
• 
Device deficiencies (DDs). 
Other exploratory 
endpoint(s): 
• 
Rate of reoperation at 6, 12 and 24 months by tear type 
(complex or HCT), demographics, procedural details 
(complex tear orientation, hybrid vs non-hybrid approach, 
types of devices used with NOVOSTITCH PRO) and 
rehabilitation protocol; 
• 
IKDC Subjective, KOOS and Lysholm scores at baseline, 6, 
12 and 24 months by tear type, demographics, procedural 
details and rehabilitation protocol; 
• 
Healing status at 6, 12 and 24 months by tear type; 
• 
Quality of Life (QoL) from EQ-5D-5L at baseline, 12, and 24 
months; 
• 
Patient Satisfaction at 12 and 24 months; 
• 
Device deficiencies when NOVOCUT Suture Manager is 
used intraoperatively; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 12 of 94 
 
• 
Analysis of the change in meniscal signal on MRI at baseline 
vs at 1 and 2 years; 
• 
Analysis of the change in cartilage signal and joint space 
narrowing as indicators of osteoarthritis on X-rays taken at 
baseline vs at 2 years. 
 
 
 
 
STUDY SCHEDULE 
 
 
Visit Type/name 
Frequency / Time point 
Visit 1: 
Screening/Consent/ 
Initial Assessment 
Day 0 
Visit 2: Procedure 
Within 8 weeks from screening 
Visit 3: 7-15 Days 
7-15 days after procedure 
Visit 4: 90 Days 
90 days +/- 14 days after procedure 
Visit 5: 185 Days 
185 days +/- 30 days after procedure 
Visit 6: 365 Days 
365 days +/- 60 days after procedure 
Visit 7: 730 Days 
730 days +/- 60 days after procedure 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 13 of 94 
 
CONTENTS 
 
3.1 
TABLE OF CONTENTS 
 
Signatures .......................................................................................................................................... 2 
1.1 
Principal Investigator Signature Page ........................................................................................ 2 
1.2 
Coordinating Investigator Approval ............................................................................................ 3 
1.3 
Sponsor Approval....................................................................................................................... 4 
Synopsis ............................................................................................................................................. 5 
Contents ...........................................................................................................................................13 
3.1 
Table of Contents .....................................................................................................................13 
3.2 
List of Tables ............................................................................................................................15 
3.3 
List of Figures ...........................................................................................................................15 
3.4 
List of Abbreviations And definitions ........................................................................................16 
Introduction ......................................................................................................................................18 
4.1 
Background ..............................................................................................................................18 
4.2 
Literature Summary .................................................................................................................20 
4.3 
Study Purpose ..........................................................................................................................21 
4.4 
Safety Considerations ..............................................................................................................21 
Objective(s) ......................................................................................................................................22 
5.1 
Primary Objective .....................................................................................................................22 
5.2 
Secondary Objective(s) ............................................................................................................22 
5.3 
Safety Objective(s) ...................................................................................................................22 
5.4 
Claims ......................................................................................................................................22 
Investigational Product(s).................................................................................................................23 
6.1 
Identification .............................................................................................................................23 
6.2 
Product Use .............................................................................................................................26 
6.3 
Packaging and Labeling ...........................................................................................................26 
6.4 
Product Accountability Procedures ..........................................................................................27 
6.5 
Surgical Technique ..................................................................................................................27 
Subject Enrollment and Withdrawal .................................................................................................28 
7.1 
Subject Population ...................................................................................................................28 
7.2 
Inclusion Criteria ......................................................................................................................28 
7.3 
Exclusion Criteria .....................................................................................................................29 
7.4 
Screening .................................................................................................................................31 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 14 of 94 
7.5 
Informed Consent.....................................................................................................................32 
7.6 
Enrollment ................................................................................................................................33 
7.7 
Lost to Follow-Up .....................................................................................................................34 
7.8 
Withdrawal ...............................................................................................................................34 
Study Design ....................................................................................................................................36 
8.1 
Study Design ............................................................................................................................36 
8.2 
Allocation and Blinding .............................................................................................................37 
8.3 
Study Endpoints .......................................................................................................................38 
8.4 
Methods Used to Minimize Bias and Maximize Validity ..........................................................40 
Study Procedures .............................................................................................................................41 
9.1 
Visits and Examinations ...........................................................................................................41 
9.2 
Study Methods and Measurements .........................................................................................49 
9.3 
Health Economics/Quality of Life .............................................................................................52 
Statistical Design ..............................................................................................................................53 
10.1 
General ....................................................................................................................................53 
10.2 
Analysis Populations ................................................................................................................54 
10.3 
Baseline Data ...........................................................................................................................54 
10.4 
Efficacy Analysis ......................................................................................................................54 
10.5 
Safety Analyses .......................................................................................................................56 
10.6 
Interim Analyses ......................................................................................................................57 
Sample Size Justification .................................................................................................................57 
Adverse Events and Device Deficiencies ........................................................................................58 
12.1 
Definitions ................................................................................................................................58 
12.2 
AE Coding Dictionary ...............................................................................................................62 
12.3 
Reporting Procedures ..............................................................................................................62 
12.4 
Unblinding of Investigational Product.......................................................................................65 
12.5 
Follow-up of Subjects with Adverse Events .............................................................................65 
Investigator Obligations....................................................................................................................66 
Sponsor and Monitor Responsibilities ..............................................................................................66 
14.1 
Site Qualification Visit ..............................................................................................................67 
14.2 
Site Initiation Visit .....................................................................................................................67 
14.3 
Sponsor Audits and Regulatory Inspection ..............................................................................67 
14.4 
Close-out Visit ..........................................................................................................................67 
Protocol Amendments ......................................................................................................................68 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 15 of 94 
Confidentiality of the Study ..............................................................................................................68 
Statements of Compliance ...............................................................................................................68 
End of Study .....................................................................................................................................68 
Publication Policy .............................................................................................................................69 
19.1 
Publication of Study Data .........................................................................................................69 
19.2 
Data Sharing ............................................................................................................................69 
References .......................................................................................................................................70 
Appendices ......................................................................................................................................75 
21.1 
Protocol Amendment 2.0 .........................................................................................................75 
21.2 
Instructions For Use .................................................................................................................86 
21.3 
Equipment and Special Instructions .........................................................................................86 
21.4 
Additional Information ..............................................................................................................86 
21.5 
Principal Investigator Obligations (ISO14155:2011) ................................................................86 
 
3.2 
LIST OF TABLES 
 
Table 9.1.1-1: Study Procedures by Visit .................................................................................................... 41 
Table 12.1-1: Categories of Adverse Event ................................................................................................. 58 
 
3.3 
LIST OF FIGURES 
Figure 6.1-1: Image of the NOVOSTITCH PRO Device… .......................................................................... 24 
Figure 8.1-1: Study Flowchart ..................................................................................................................... 37 
Figure 12.3-1: Evaluation and Reporting of AE ........................................................................................... 64 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 16 of 94 
3.4 
LIST OF ABBREVIATIONS AND DEFINITIONS 
 
 
 
Abbreviation 
Definition 
ACL 
Anterior Crucial Ligament 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
ASADE 
Anticipated Severe Device Effect(s) 
BMI 
Body Mass Index 
CAR 
Clinical Activity Report 
CI 
Confidence Interval 
CRF 
Case Report Form(s) 
CV 
Curriculum Vitae 
DD 
Device Deficiency(ies) 
FAS 
Full Analysis Set Population 
FU 
Follow-Up 
GCP 
Good Clinical Practice 
HIPAA 
Health Information Portability Accountability Act 
HCT 
Horizontal Cleavage Tear 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
IKDC 
International Knee Documentation Committee 
IMDRF 
International Medical Device Regulators Forum 
IP 
Investigational Product 
IRB 
Institutional Review Board 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
 
Study Protocol 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: 17 of 94 
 
Abbreviation 
Definition 
ISF 
Investigator Site File 
ISO 
International Organization for Standardization 
JSN 
Joint Space Narrowing 
KOOS 
Knee Injury and Osteoarthritis Outcome Score 
LAR 
Legally Authorized Individual 
MCID 
Minimal Clinically Important Difference 
MRI 
Magnetic Resonance Imaging 
NA or N/A 
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
OA 
Osteoarthritis 
PI 
Principal Investigator 
PP 
Per-protocol Population 
PRO 
Patient Reported Outcomes 
QoL 
Quality of Life 
S+N 
Smith + Nephew, Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety population 
SAP 
Statistical Analysis Plan 
TKA 
Total Knee Arthroplasty 
USADE 
Unanticipated Serious Adverse Device Effect(s) 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 18 of 94 
 
INTRODUCTION 
 
4.1 
BACKGROUND 
 
The meniscus is an important component of the knee that is involved in stability and shock 
absorption as well as lubrication and distributing nutrients to the articular cartilage.1-4 Because of 
their location, menisci are highly susceptible to injury.1 The most common mechanism of injury is 
trauma during sports activity and often occurs in combination with anterior cruciate ligament 
(ACL) injury.5,6 Degenerative injury is also possible and may signify the onset of osteoarthritis 
(OA).7 
 
Meniscal tear pattern and location have a direct effect on healing potential; tear patterns include 
radial, longitudinal, horizontal, and complex lesions. The central third of the meniscus, known as 
the white zone, has less healing potential than the middle third, known as the red-white zone, 
and the peripheral third, known as the red zone.8,9 Tears along the outer edge of the meniscus 
have superior healing potential as blood supply is more available in that area than in the inner 
two-thirds of the meniscus.1 Horizontal cleavage tears are meniscal tears that extend from the 
inner free margin of the meniscus into the intra-meniscal substance. These tears typically 
extended into the avascular zone, which can affect their ability to heal, and have been 
historically treated with partial meniscectomy.10 Tears that occur over a long period of time are 
considered degenerative and are typically complex tears.11 Complex tears are where two or 
more tear patterns exist; they are more common in the elderly and have associated osteoarthritic 
changes in the knee.11 There are several options when treating meniscal tears, including non- 
operative treatment (physical therapy), partial meniscectomy, and meniscal repair. 
 
Non-operative treatment including physical therapy can be successful in treating some meniscal 
tears. In a systematic review conducted by Monk et al.3, the outcomes of meniscal resection 
(debridement) versus physical therapy was analyzed. It was determined that there was a 
difference between the two groups in the short term, but both groups still met the minimally 
important difference. The long term differences were not statistically significant between the two 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 19 of 94 
 
groups. For patients who do not respond to physical therapy, surgical treatment is 
recommended.3 
 
Partial meniscectomy with single leaflet resection has been recommended to relieve symptoms, 
preserve meniscal tissue, and create a stable construct.12 Evidence has shown minimal 
biomechanical benefit for single leaflet resection because the total contact area decreases by 
82% and the peak contact pressure is similar to that of dual leaflet resection.13,14 
 
In the US, of the estimated 850,000 cases per year, 10% to 20% of orthopedic surgeries involve 
surgical repair of the meniscus.15 A recently developed meniscal technique is the all-inside repair 
technique.9 In this approach, the surgeon uses posterior accessory portals and suture hooks to 
shuttle sutures through meniscal tears of the posterior horn that were not easily repairable using 
the other approaches. This approach can reduce surgical time8, doesn’t require an open  
incision, and can prevent complications seen with the external approaches.16 Disadvantages of 
the external approach can include neurovascular injury16, cysts, device migration or device 
breakage.17 
 
NOVOSTITCH PRO, a meniscus suture-passing device, enables placement of a circumferential 
compression stitch by use of a low-profile curved upper jaw, as well as a protractible retractable 
lower jaw, to allow reversible encasement of the meniscus without injury to surrounding 
structures. Circumferential stitching for meniscus repair has been shown in the laboratory to 
impact root repair strength by 38-70% stronger18, normalize horizontal cleavage tear contact 
pressures19 and be stronger than inside-out for radial repairs20. Recent technique studies have 
highlighted methods of using NOVOSTITCH PRO to deliver circumferential compression stitch 
repairs in an all-inside manner21,22. However, to date there is very limited data that documents 
the clinical success of horizontal cleavage and complex repairs with NOVOSTITCH PRO. A 
summary of known and potential risks and benefits to humans can be found in the 
NOVOSTITCH PRO Instructions for Use (IFU). 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 20 of 94 
 
4.2 
LITERATURE SUMMARY 
 
A systematic review of the literature of isolated meniscal repair was performed by O’Donnell et 
al.23 Success rates ranged from 62%-100%, with one study reporting a 25% success rate. In 
comparing the tear types, a systematic review performed by Kurzweil et al.10 reported success 
rates of horizontal repairs was 76%, bucket handle tears was 84% and vertical tears was 68%. 
Rubman et al.24 published their series of 198 complex repairs that extended into the avascular 
zone, and 80% were clinical successful with 20% requiring reoperation. 
 
Smith and Dougherty presented an unpublished manuscript of a retrospective case series of 19 
patients who underwent an all-inside meniscal repair using the NOVOSTITCH PRO device and 
reported IKDC outcome scores.25 The NOVOSTITCH PRO device was used to deliver 2-0 non- 
absorbable ultra high molecular weight polyethylene suture. The mean number of stitches 
delivered was 3.3, ranging from 1-7. Mean postoperative IKDC subjective score was 83 (range 
52-100) at an average of 18 months postop (range 14-24 months). Two of these patients 
returned for a reoperation of the meniscus due to (1) re-injury during sporting event and (1) stitch 
failure. Apart from the reoperation due to stitch failure, there were no other device specific 
complications reported. Additional records of 36 patients who were treated with the 
NOVOSTITCH PRO device during the same timeframe, but did not report IKDC results were 
reviewed, and one reoperation was reported due to non-compliance with the rehab protocol. 
 
Kurzweil et al. presented an abstract on a non-randomized multicenter study of 30 patients 
treated with the NOVOSTITCH PRO (referred to as STITCH 1.0 study).26 Six patients were lost 
to follow-up and 24 patients were included in the one year follow-up. Two patients required 
reoperation, reason for revision was not discussed. Significant improvement in KOOS, Tegner, 
IKDC and Lysholm scores were reported. 16/24 (66.7%) and 15/24 (62.5%) of patients met the 
minimal clinically important difference (MCID) for improvement in IKDC and Lysholm scores, 
respectively. These subjects are to be followed for 2 years. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 21 of 94 
 
4.3 
STUDY PURPOSE 
 
The purpose of this post-market study is to collect safety and clinical outcomes data from 
patients with horizontal cleavage tear (HCT) and complex tears who underwent meniscal repair 
with the NOVOSTITCH PRO Meniscal Repair System. Increasing evidence suggest that a 
broader set of meniscal tears, such as vertical, longitudinal, radial, complex, HCT, may be more 
repairable than previously thought.10,27,28 The feasibility of repairing HCT and complex tears is 
still unclear; these tears have been thought to have minimal healing capacity with current 
available surgical techniques as they are often located within the avascular zone. As such, this 
study will begin that process by examining and documenting the ability to successfully repair 
horizontal cleavage and complex meniscus tears using all-suture based techniques. 
 
4.4 
SAFETY CONSIDERATIONS 
 
Potential Adverse Effects listed in the IFU include: 
 
• 
Wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact 
with salt solutions such as urine and bile occur, infected wounds, minimal acute 
inflammatory reaction and transitory local irritation; 
• 
As with any foreign body, prolonged contact with this suture with salt solutions, such as 
those found in urinary or biliary tracts, may result in calculus formation; 
• 
Allergies and other reactions to device materials. 
 
Potential Device Deficiencies for the product include, but are not limited to, the following: 
 
• 
Suture deployed prematurely; 
• 
Handle does not fully retract; 
• 
Lower jaw does not retract; 
• 
Distal or central miss in which the suture does not go through the meniscus; 
• 
Suture cartridge not loaded properly / suture cartridge not in track; 
• 
Suture drop from the upper jaw where the suture pulls out of the meniscus. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 22 of 94 
 
OBJECTIVE(S) 
 
The primary, secondary, and safety objectives of this study are listed as follows. 
 
5.1 
PRIMARY OBJECTIVE 
 
The primary objective of this study is to assess clinical success rate of NOVOSTITCH PRO at 12 
months, defined as rate of freedom from reoperation due to meniscal repair failure in the study 
knee. 
 
5.2 
SECONDARY OBJECTIVE(S) 
 
The secondary objectives are to: 
• 
Assess the clinical success rate of NOVOSTITCH PRO at 6 months, defined as rate of 
freedom from reoperation due to meniscal repair failure in the study knee; 
• 
Assess the clinical success rate of NOVOSTITCH PRO at 24 months, defined as rate of 
freedom from reoperation due to meniscal repair failure in the study knee; 
• 
Assess clinical performance of NOVOSTITCH PRO by Patient Reporting Outcomes 
(PROs) including the Knee Injury and Osteoarthritis Outcome Score (KOOS), 
International Knee and Documentation Committee (IKDC) Subjective, and Lysholm; 
• 
Evaluate pre- and post-procedure magnetic resonance imaging (MRI) and radiographs, 
and post-procedure needle endoscopy. 
 
5.3 
SAFETY OBJECTIVE(S) 
 
Assess safety with reported complications, adverse events, adverse device effects, 
unanticipated serious adverse device effects, and device deficiencies. 
 
5.4 
CLAIMS 
 
The proposed Marketing Claims for this study include, but are not limited to, the following: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 23 of 94 
 
• 
HCT and Complex meniscal tears repaired with NOVOSTITCH PRO have a clinical 
success rate of 80% or higher; 
• 
HCT and Complex meniscal tears repaired with NOVOSTITCH PRO have reoperation 
rates similar to other commonly repaired tear types (<20%); 
• 
HCT meniscal tears repaired with NOVOSTITCH PRO lead to a significant improvement 
in patient symptom scores; and 
• 
Complex meniscal tears repaired with NOVOSTITCH PRO lead to a significant 
improvement in patient symptom scores. 
 
INVESTIGATIONAL PRODUCT(S) 
 
The Meniscal repair device used in the investigation will be the NOVOSTITCH PRO Meniscal 
Repair System, expressly intended for approximation of soft tissue in meniscal repair 
procedures. The system is 510(k) cleared in the United States and available for use with size 2-0 
or 0 ultra-high-molecular-weight polyethylene suture cartridges. 
 
6.1 
IDENTIFICATION 
 
6.1.1 
Investigational Product 
 
The NOVOSTITCH PRO Meniscal Repair System is a system with a pre-loaded implant 
designed for all-suture, all-inside meniscal repair procedures. The device is 510(k) cleared in the 
United States with an indication of “NOVOSTITCH PRO is intended for approximation of soft 
tissue in meniscal repair procedures.” The use of the NOVOSTITCH PRO device in this post- 
market study is consistent with this cleared indication for use and not investigational. The study 
is designed to further demonstrate repair success in a subset of meniscal repairs for potential 
comparison to other known treatment methods in order for surgeons to determine the best 
potential treatments for those patients. The devices being used in this study are: 
 
• 
NOVOSTITCH PRO Meniscal Repair System, size 2-0 (product number: CTX-A003) 
• 
NOVOSTITCH PRO Meniscal Repair System, size 0 (product number: CTX-A004) 
• 
NOVOSTITCH Meniscal Repair Cartridge, size 2-0 (product number: CTX-R001) 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 24 of 94 
 
• 
NOVOSTITCH Meniscal Repair Cartridge, size 0 (product number: CTX-R002) 
Figure 6.1-1: Image of the NOVOSTITCH PRO Device 
 
 
The NOVOSTITCH PRO non‐absorbable surgical suture is supplied sterile in 80 cm lengths 
preloaded in the device. 
 
• 
The size 2‐0 suture is composed of undyed (white) ultra‐high‐molecular‐weight 
polyethylene braided with one or two strands of blue polypropylene to add color. 
• 
The size 0 suture is composed of undyed (white) ultra‐high‐molecular‐weight 
polyethylene braided with two strands of green polyethylene terephthalate to add color. 
 
Refer to the NOVOSTITCH PRO Instructions for Use for more information. 
Contraindications for use include the following: 
• 
The device is not to be used on bone or other hard tissue. 
• 
Surgical procedures other than those listed in the INDICATION FOR USE section. 
• 
Presence of infection. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 25 of 94 
 
• 
Patient conditions including insufficient quantity or quality of tissue. 
• 
Insufficient blood supply or previous infections which may hinder the healing process. 
• 
Foreign body sensitivity. If material sensitivity is suspected, testing should be completed 
prior to suture implantation. 
• 
Conditions which may limit the patient’s ability or willingness to follow postoperative care 
instructions. 
 
The NOVOSTITCH PRO and its cartridges are covered by numerous method and device 
patents issued in the US which indicate that the device is designed for use in meniscal repair 
procedures. The intellectual property does not cover any investigational materials or biologics 
relevant to this study. 
 
Each surgery in the study typically requires: 
 
• 
1 NOVOSTITCH PRO Meniscal Repair System, which consists of a handle and one pre- 
loaded replacement cartridge filled with either 2-0 or 0 suture (CTX-A003 or CTX-A004, 
respectively); 
• 
Between 0-6 additional NOVOSTITCH Cartridges filled with either 2-0 or 0 suture (CTX- 
R001 or CTX-R002, respectively). The average procedure uses 2 replacement 
cartridges. 
 
The legal manufacturer for the NOVOSTITCH PRO device is: 
 
Smith + Nephew, Inc. 
150 Minuteman Rd. 
Andover, MA 01810 
 
6.1.2 
Comparator Treatment 
 
No comparator treatment will be used for this study. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 26 of 94 
 
6.1.3 
Ancillary Product 
 
No ancillary products will be used related to the direct repair of investigated meniscus. 
 
6.2 
PRODUCT USE 
 
Typically, total meniscal repair procedure time runs for approximately 45 minutes, during which 
the NOVOSTITCH PRO is used in the knee for approximately 5-30 minutes. 
 
Potential adverse reactions related to treatment and or exposure to associated treatment 
materials include: 
 
• 
Adverse effects associated with the use of the device, including wound dehiscence, 
calculi formation in urinary and biliary tracts with prolonged contact with salt solutions 
such as urine and bile occur, infected wounds, minimal acute inflammatory tissue 
reaction and transitory local irritation. 
• 
As with any foreign body, prolonged contact of the suture with salt solutions, such as 
those found in urinary or biliary tracts, may result in calculus formation. 
 
Refer to the NOVOSTITCH PRO IFU for detailed information on contraindications, warnings, 
adverse reactions and precautions. 
 
6.3 
PACKAGING AND LABELING 
 
Packaging and labeling will be as per commercially available product and will meet regulatory 
requirements. 
 
6.3.1 
Labeling of Investigational Product 
 
The NOVOSTITCH PRO Meniscal Repair System, has received 510(k) clearance in the United 
States. All devices used in this study will be procured in standard commercial packaging, 
ordered via normal and customary Smith + Nephew procedures and managed per study site 
processes. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 27 of 94 
 
The NOVOSTITCH PRO Meniscal Repair System and Suture Cartridges contain the following 
information: 
 
• 
Lot Number 
• 
Catalog Number 
• 
Unique Device Identifier 
• 
Package contents 
• 
Use by Date 
• 
Date of Manufacture 
• 
Distributor information: Smith + Nephew, Inc. 
• 
Manufacturer name and address 
• 
Product name and cartridge size 
• 
Customer service contact information 
• 
Product sale restriction 
 
6.4 
PRODUCT ACCOUNTABILITY PROCEDURES 
 
Sites will be responsible for obtaining and maintaining an inventory of NOVOSTITCH PRO. Sites 
will document the device that was used in a subject on a CRF that will include unique identifiers. 
The CRFs will also document any device deficiencies, including if any products were wasted or 
returned to the Sponsor. All records must be available for inspection by the Sponsor, its 
designees, or by regulatory agencies at any time. As part of monitoring, the Study Monitor will 
check that site personnel are following the proper procedures for completing all necessary 
documentation. 
 
6.5 
SURGICAL TECHNIQUE 
 
All study related procedures with the NOVOSTITCH PRO Meniscal Repair System must be 
performed according to the recommended surgical technique described in the IFU. Surgeons 
selected to participate in this study will be familiar with the NOVOSTITCH PRO product, or will 
receive training prior to enrolling any subjects per standard SN procedures if not familiar. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 28 of 94 
1. 
Able and willing to give informed consent by voluntarily providing written informed 
consent in accordance with governing Institutional Review Board; 
2. 
18 to 70 years of age, inclusive at the time of screening; 
3. 
History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as 
locking, clicking or giving way); 
4. 
Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness 
and/or pain on meniscal compression); 
5. 
If prior ligament reconstruction, the study knee is clinically stable; 
6. 
Meniscal repair to be performed arthroscopically; 
 
SUBJECT ENROLLMENT AND WITHDRAWAL 
 
7.1 
SUBJECT POPULATION 
 
This study will enroll 90 subjects between the ages of 18 and 70 years of age. Although 
horizontal cleavage and complex meniscal tears can occur in any age group, enrolling subjects 
18-70 years of age allows inclusion of knees with less likelihood of growth changes or significant 
arthritic changes which may mask measurement of knee pain and function improvements 
following the treatment procedure. Subjects will be enrolled at a minimum of 3 sites, and a 
maximum of 8 sites, across the United States. 
 
Ethnic minorities are classed as vulnerable subjects according to International Organization for 
Standardization (ISO) 14155:2011 however they will be included providing they meet other 
inclusion criteria and there are informed consent documents and personnel to lead the consent 
process in a language that is fully understood by the potential subject. 
 
7.2 
INCLUSION CRITERIA 
 
Subjects will be considered qualified for enrollment if they meet the following criteria at 
screening: 
 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 29 of 94 
 
 
 
Consented subjects may be included in the study only if, upon arthroscopic inspection, their 
meniscal study lesion meets all of the following criteria: 
 
 
 
7.3 
EXCLUSION CRITERIA 
 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
 
1. 
Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher); 
2. 
Body Mass Index (BMI) ≥40 kg/m2; 
3. 
Previous surgical meniscal repair or meniscectomy of the study meniscus; 
4. 
Unstable knee; 
5. 
Clinically significant malalignment of the study knee, and/or requiring osteotomy, and/or 
correction; 
1. 
Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of 
adjunct devices per the exclusion criteria; 
2. 
Tear pattern is one of the following: 
a. Horizontal cleavage tear (HCT), 
b. Complex multi-planar tear (combination of at least two of the following tears: 
horizontal, oblique, radial, vertical). 
7. 
Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus 
tear in the symptomatic compartment; 
8. 
Willing and able to comply with all study procedures and visit requirements, including 
MRIs, X-rays, and Case Report Forms (CRFs) completed by the subject. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 30 of 94 
1. 
Ramp tears; 
2. 
Root or other tear type requiring tibial fixation; 
3. 
Tears requiring repair of both meniscus in the study knee; 
 
6. 
History of constitutional/systemic inflammatory/arthritic problem or pain condition, history 
of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, and/or 
HIV; 
7. 
Currently on any immunosuppressive therapy; 
 
8. 
Expected to undergo any other surgical treatment of either knee; 
 
9. 
Previously enrolled in the study (no bilateral knee surgeries); 
 
10. 
Surgical procedures other than those listed in the Indications for Use; 
 
11. 
Patient conditions including insufficient quantity or quality of tissue; 
 
12. 
Insufficient blood supply or previous infections which may hinder the healing process; 
 
13. 
Foreign body sensitivity. If material sensitivity is suspected, testing should be completed 
prior to suture implantation; 
14. 
Conditions which may limit the patient’s ability or willingness to follow postoperative care 
instructions; 
15. 
Any concomitant painful or disabling disease, condition or post-procedure status of either 
lower extremity that would interfere with evaluation or rehabilitation of the study knee; 
16. 
Pregnant or planning to become pregnant in the next 2 years; 
 
17. 
Subject does not understand a language in which the PROs and EQ-5D-5L are available. 
 
 
Subjects will be excluded from the study if their study meniscus lesion meets any of the following 
criteria at arthroscopy: 
 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 31 of 94 
 
 
 
 
7.4 
SCREENING 
 
Subjects will be recruited for the study through the clinical practices of the Investigators. 
 
Of the 90 subjects, at least 40 subjects will have horizontal cleavage meniscal tears and at least 
40 will have complex meniscal tears. Subjects will be enrolled as they meet eligibility and 
4. 
Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not 
require repair; 
5. 
Poor meniscal tissue quality such that it will not hold a suture; 
6. 
For HCTs: 
a. Use of any capsular fixation device; OR 
b. Any portion of the meniscal tear is repaired using a device to place stitches 
other than NOVOSTITCH PRO, Meniscus Mender II, or Meniscal Stitcher, 
FIRSTPASS MINI marketed by Smith + Nephew, Inc.; 
7. 
For complex tears: 
a. Any portion of the meniscal tear is repaired using a device to place stitches 
other than NOVOSTITCH PRO, Meniscus Mender II, Meniscal Stitcher, 
FIRSTPASS MINI, FAST-FIX 360, or ULTRA FAST-FIX marketed by Smith + 
Nephew Inc.; 
8. 
Clinically significant (zone 1 and/or zone 2) tear in the contralateral compartment to the 
study meniscus; 
9. 
Performance of a significant concomitant procedure (e.g. ACL reconstruction or repair, 
cartilage repair or restoration) intended as a therapeutic intervention on the study knee; 
10. 
Presence of infection; 
11. 
Articular cartilage damage in the study knee, defined as Modified Outerbridge Grade III 
or higher. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 32 of 94 
 
consent to the study. Therefore, if a group enrolls 50 subjects, screening will stop within that 
group, and screening and enrollment will continue only in the other group until all 90 subjects are 
enrolled. 
 
Participating study sites are required to document all screened subjects considered for inclusion 
in this study. If a subject is excluded from the study, the reasons for exclusion will be 
documented in the subject's source documents and noted on the Screening and Enrollment Log. 
All screening activities that occur prior to consent shall be referred to as pre-screening. 
 
Part of the screening process will include documentation of women’s childbearing potential. If 
the woman is not of childbearing potential this should be documented in the medical history 
(e.g., surgically postmenopausal, postmenopausal [i.e., at least one year without menses]). For 
women of childbearing potential, their method of birth control should be documented in the 
source. Acceptable birth control methods include abstinence, condoms, birth control pills, IUDs, 
and other hormonal or physical methods. 
 
7.5 
INFORMED CONSENT 
 
Before conducting any study procedures or examinations, the purpose and nature of the study 
must be explained to the subject in their native language. The subject will be allowed to ask any 
questions and consider whether he or she would like to participate in the study. He/she may 
consent to the study when it is introduced, or may wish to take time to review the study, 
including, but not limited to, speaking to friends and family about participation in the study. 
Consent cannot be coerced and must be completed at any time prior to the first study activity. 
 
If the subject consents to the study, or their legally authorized representative (LAR) agrees to 
the study, the subject or LAR will then read, sign, and personally date the Institutional Review 
Board (IRB)-approved informed consent document(s) (see below non-English speakers and for 
difficulties with reading and writing). Signature may be handwritten or electronic if a secure and 
compliant e-consent process is used. Additionally, the individual who obtains consent from the 
subject will sign and date the informed consent document. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 33 of 94 
 
If the subject does not speak English, the individual will be given a consent form in their native 
language, or a bilingual study member or an in-person or telephone interpreter will be used and 
the entire consent form will be translated for the subject. The subject will be able to ask any 
questions that will be answered by study personnel, and as required through the use of the 
interpreter. If an interpreter is used, the subject will sign a short consent form, along with a 
witness, and documentation of the translator will be included on the form. A copy of the signed 
consent form, or short informed consent document and a copy of the English consent form as 
applicable, will be provided to the subject, and copies will be placed in the subject’s record or 
chart as required by the site, with the original filed in the Investigator Site File (ISF). 
 
If the subject is unable to read, the informed consent document and associated study 
information may be read aloud to the subject in the presence of an impartial witness. If possible, 
the subject shall sign and personally date the Informed Consent Form (ICF). Where this is not 
possible, due to difficulties in writing, the subject shall provide verbal consent to participate in the 
study. The witness shall then personally sign and date the informed consent form, attesting that 
the information was accurately explained and that the informed consent was freely given. 
 
In the case of vulnerable subjects, the ICF must be understood and signed by the subject’s 
legally authorized representative (parent or legal guardian). If the legally authorized 
representative is unable to read/write, a witness signature is required as described previously. 
 
As required by the IRB and the site, all Health Information Portability Accountability Act (HIPAA) 
regulations and documentation will be followed. 
 
7.6 
ENROLLMENT 
 
Subjects for whom the consent process has been completed and have been treated with the 
study product are considered enrolled. Any subjects who have provided consent but do not 
receive treatment or withdraw consent prior to surgery will be considered a screen fail. 
 
Subjects will be assigned a Subject ID at the time of consent. Subjects with bilateral meniscal 
repair will not be enrolled. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 34 of 94 
 
7.7 
LOST TO FOLLOW-UP 
 
A subject will be considered lost to follow-up if he/she does not appear for the scheduled study 
visit for 2 consecutive visits and does not return for a final visit, and study personnel are unable 
to contact the subject. 
 
Some actively enrolled subjects will not return for follow-up exams on time; any visits not 
completed on-time will be considered protocol deviations. Study personnel must make a 
reasonable effort to contact the subject and document the following contact attempts before 
declaring a subject to be lost to follow-up: the subject has been contacted according to the site's 
policies, but no fewer than two documented phone or text contacts and one certified letter 
without response. Subjects may also be contacted by email. Copies of all attempts to reach the 
subjects by phone, mail, or email and/or the attempts to contact the subject via other means 
should be documented, and that documentation should be kept with the subject’s source 
documents. 
 
7.8 
WITHDRAWAL 
 
Subjects may be withdrawn from the study per the reasons listed below. 
 
7.8.1 
Withdrawal from Study 
 
The Investigator may withdraw subjects from the study for many reasons, including but not 
limited to the following: 
 
• 
Subject noncompliance (e.g., did not follow instructions, took disallowed medications) or 
misses 2 consecutive study visits; 
• 
Subject lost to follow-up; 
• 
If the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study; 
• 
Concurrent debilitating illness; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 35 of 94 
 
• 
Adverse Events/Adverse Device Effects that affect the ability to evaluate the study product 
without bias; 
• 
Any other significant reason identified by the Investigator. 
 
If a subject receives a revision surgery of the study knee, or experiences an AE/SAE/DD, the 
subject shall continue to have follow-up visits in order to monitor the subject’s health status until 
any adverse events/adverse device events are resolved, is lost to follow-up, or until 24 months 
post-surgery. Potential data following the revision surgery will not be included as study data but 
presented separately as safety data. Revision subjects will not be replaced. 
 
For each case, information will be obtained in the source document and entered on the End of 
Study Case Report Form (CRF) detailing circumstances leading to the withdrawal. 
 
Subjects who drop out or are withdrawn will be re-entered into the study at a later date if he or 
she returns to the site for a subsequent follow-up visit, has not received a revision surgery of the 
study knee, or was withdrawn for a medical reason that is resolved, and the Principal 
Investigator (PI) agrees to re-entry in the study. Subjects who are withdrawn from the study will 
not be replaced. 
 
7.8.2 
Subject’s Withdrawal of Consent to Participate in Study 
 
Study participation is voluntary, and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the Investigator should make 
a reasonable effort to ascertain the reason(s), while fully respecting the subject’s privacy. The 
reason for withdrawal will be recorded in the CRF and source documents. No further study 
activities will occur once a subject withdraws consent. 
 
If a subject withdraws, he/she will not be replaced. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 36 of 94 
 
7.8.3 
Use of Data Following Withdrawal 
 
In cases where the subject withdraws consent, or the subject is withdrawn from the study by the 
PI, data collected up to the point of withdrawal may be used, but no additional data for that 
subject may be collected except for subjects who have consented and have an adverse event 
that is being followed to resolution or receive a revision surgery of the study knee as detailed in 
section 7.8.1 above. 
 
STUDY DESIGN 
 
8.1 
STUDY DESIGN 
 
This is a prospective, multi-center, non-randomized clinical trial. The study is divided into 2 
groups that are allocated by tear type at surgery: 
 
o Horizontal cleavage meniscal tear, 
o Complex meniscal tear. 
 
This study will enroll at up to 8 clinical sites in the United States, with a minimum of 3 sites. 
 
The study is expected to be 42 months in duration, but will depend on enrollment rate. This 
includes: 
• 
16 months for enrollment 
• 
26 months for follow-up 
o The final visit is 24 months post-surgery and includes a +/-2-month window 
period. 
 
Treatment of the study meniscus will occur once, in the form of a surgery to repair the torn 
portion of the meniscus. 
 
This study was designed as a prospective, multi-center, non-randomized study of repairs of 
horizontal cleavage and complex tears of the meniscus using commercially available products. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 37 of 94 
 
No formal hypotheses testing will be done. However, primary outcome measures that will be 
examined include whether the reoperation survival rate at 12 months will be similar or less than 
historical rates (78-91%)10,27; whether a significant proportion of the subjects will show meniscus 
healing at 6 months; and whether Patient Reported Outcomes (PROs) will be improved up to 2 
years following the procedure. 
 
Figure 8.1-1: Study Flowchart 
 
 
 
8.2 
ALLOCATION AND BLINDING 
 
8.2.1 
Treatment Allocation 
 
This study is not randomized. Subjects will be enrolled in the horizontal cleavage tear or 
complex tear group pending the type of meniscal tear at surgery. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 38 of 94 
 
8.2.2 
Blinding 
 
This study is not blinded. 
 
8.3 
STUDY ENDPOINTS 
 
8.3.1 
Primary Endpoint 
 
The primary endpoint of this study is rate of reoperation due to meniscal repair failure at 12 
months post-operative. 
 
This endpoint is a clinically relevant measure of repair success that surgeons use, and the 
percentage of reoperations for a given tear type in the literature impacts how surgeons choose 
to treat that tear type. 
 
8.3.2 
Secondary Endpoints 
 
Following are the secondary endpoints for this study: 
 
• 
Rate of reoperation due to meniscal repair failure at 6 and 24 months post-operative; 
• 
MRI of structural integrity of meniscus at baseline, 12 months and 24 months; 
• 
Radiographs to evaluate tibiofemoral joint space narrowing (JSN) at baseline and 24 
months; 
• 
Results of in-office needle endoscopy at 6 months, if available; 
• 
Patient Reported Outcomes (PRO) data will be collected on IKDC, KOOS & Lysholm 
score for baseline and 6, 12 and 24 month follow-up time points. 
 
The secondary endpoints provide more context on whether the meniscal repair was a success at 
earlier time points and whether it is durable for two years. MRI and endoscopy measurements 
allow surgeons to assess meniscal healing, whether a reoperation is performed or not. 
Radiographs of joint space narrowing (JSN) will indicate whether patients have progressively 
worse osteoarthritis which is an indicator for future risk of needing a Total Knee Arthroplasty 
(TKA). PROs provide meaningful quality of life measurements to assess improvement, which is 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 39 of 94 
 
ultimately the clinical goal of any successful meniscal repair. IKDC Subjective, KOOS, and 
Lysholm scores are common validated tools to measure patient symptoms associated with 
meniscal function. 
 
8.3.3 
Safety Endpoints 
 
Following are the safety endpoints for this study: 
 
• 
Device-related re-intervention; 
• 
All adverse events (AEs) occurring from the time of surgery until revision or study 
completion; 
• 
Device related AEs (ADEs) and serious adverse events (SAE’s); 
• 
Device deficiencies (DDs). 
 
All safety events will be documented on the appropriate CRF and followed either until resolution 
or marked as unresolved at the end of study. All AEs will be categorized in terms of seriousness 
and relatedness to the study device or to the surgical procedure. All Serious Adverse Device 
Effects will be further categorized as Anticipated or Unanticipated. The definitions for each of 
these categories are based on ISO 14155:2011. 
 
8.3.4 
Exploratory Endpoints 
 
Exploratory endpoints proposed, but not limited to, the following: 
 
• 
Rate of reoperation at 6, 12 and 24 months by tear type (complex or HCT), 
demographics, procedural details (complex tear orientation, hybrid vs non-hybrid 
approach, types of devices used with NOVOSTITCH PRO) and rehabilitation protocol; 
• 
IKDC Subjective, KOOS and Lysholm scores at baseline, 6, 12 and 24 months by tear 
type, demographics, procedural details and rehabilitation protocol; 
• 
Healing status at 6, 12 and 24 months by tear type; 
• 
Quality of Life (QoL) from EQ-5D-5L at baseline, 12, and 24 months; 
• 
Patient Satisfaction at 12 and 24 months; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 40 of 94 
 
• 
Device deficiencies when NOVOCUT Suture Manager is used intraoperatively; 
• 
Analysis of the change in meniscal signal on MRI at baseline vs at 1 and 2 years; 
• 
Analysis of the change in cartilage signal and joint space narrowing as indicators of 
osteoarthritis on X-rays taken at baseline vs at 2 years. 
 
8.4 
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY 
 
Balanced Covariates 
 
The inclusion/exclusion criteria will be generalizable and applicable to the widest possible subset 
of the population needing meniscal repair procedures. These criteria will be uniformly applied so 
as to enroll a cohort of subjects with similar symptoms and clinical requirements. This should 
maximise the applicability to as many subjects with similar baseline characteristics and help to 
bolster external validity. 
 
Subject Attrition 
 
Subject attrition due to reduction in sample size required for precision analysis has been 
accounted for in the sample size calculation so that the estimate of the confidence interval (CI) 
to be obtained will still be valid through the most efficient use of available subjects. 
 
Pre-specification of Statistical Analysis 
 
The primary outcome measure has been pre-specified as well as the type of statistical analysis 
to be performed to evaluate repair failure rate so as to minimize reporting bias. The precision 
analysis planned for the study includes construction of confidence intervals for the outcome 
summaries and a pre-defined range in which the 95% CI for the primary outcome are expected 
to fall within are designed to maximize the validity of the study results. 
 
More detailed information on analyses to be carried out will be incorporated in the Statistical 
Analysis Plan (SAP) so as to minimize any threats to external validity in order to yield clinically 
relevant estimates of effects and precision. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 41 of 94 
 
STUDY PROCEDURES 
 
9.1 
VISITS AND EXAMINATIONS 
 
9.1.1 
Summary 
 
For a summary of the required procedures by visit, refer to the Study Schematic Table 9.1-1: 
Study Procedures by Visit. Not included directly in the table are unscheduled visits and 
reoperations, which will be completed as required for the study. 
 
Table 9.1.1-1: Study Procedures by Visit 
 
Activity 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Screen 
< 8 weeks 
pre-op 
Procedure 
7-15 
Days 
post-op 
90 Day 
±14 days 
post-op 
185 Day 
±30 days 
post-op 
365 Day 
±60 days 
post-op 
730 Day 
±60 days 
post-op 
Informed Consent 
X 
Screening Inclusion/ 
Exclusion 
X 
Demographics/Medical 
History/Concomitant 
Medications/ 
Concomitant Therapies 
X 
Radiographs 
X1,2 
X1 
MRI 
X2 
X3 
X3 
PRO: KOOS4 
X 
X 
X 
X 
PRO: IKDC Subjective4 
X 
X 
X 
X 
PRO: Lysholm4 
X 
X 
X 
X 
EQ-5D-5L CRF4 
X 
X 
X 
End of Study Form 
X
5 
X
5 
X
5 
X
5 
X
5 
X
5 
X
5 
Review General Health/ 
Concomitant 
Medications/ 
Concomitant Therapies 
X 
X 
X 
X 
X 
X 
Arthroscopy Inclusion/ 
Exclusion 
X 

Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 42 of 94 
Inter-operative 
Images/Videos 
X6
Study Surgery 
Procedure 
X 
Details of Surgery 
Procedure CRF 
X 
Details of Pathology 
CRF 
X 
Details of Post- 
Operative Plan CRF 
X 
Safety Assessment 
(AE/SAE/ADE/DD)7 
X 
X 
X 
X 
X 
X 
Review Post-Operative 
Plan/Return to Work 
CRF4 
X 
In-office Needle 
Endoscopy 
X8
Patient Satisfaction 
CRF4 
X 
X 
1Standing AP X-ray; Radiographic CRF completed by reader post-visit 
2Within 6 months prior to procedure; MRI CRF completed by reader post-visit 
3MRI 1.5 T or greater, no contrast, to be reviewed by independent radiologist appointed by sponsor 
4CRF completed by subject 
5As applicable 
6If available, still photographs and diagrams of procedure; Image CRF completed post-visit 
7If the AE/SAE/ADE/DD includes an unscheduled visit or reoperation, the Unscheduled Visit or Reoperation CRFs 
will be completed as applicable 
8If available; Endoscopy CRF completed post-visit 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 43 of 94 
1. 
Obtain written informed consent from the subject as detailed in Section 7.5 
----- Do not proceed until consent has been obtained ----- 
 
Subjects may complete the patient CRFs (PROs (KOOS, IKDC Subjective, and Lysholm), Post- 
Operative Plan/Return to Work, Patient Satisfaction, and EQ-5D-5L) either on paper, or on a 
secure electronic device such as a computer, mobile phone, or tablet. 
 
Subjects who are unable to return to the site for follow-up visits may complete the PROs (KOOS, 
IKDC Subjective, and Lysholm), Post-Operative Plan/Return to Work, Patient Satisfaction, and 
EQ-5D-5L CRFs on paper and return by mail, electronically by email, or online through a secure 
link provided by the site. The follow-up general health/concomitant medications and concomitant 
therapies CRF and safety assessment may be conducted over the telephone with study staff. As 
required, documents will be translated into the appropriate language for the individual, and an 
interpreter will be used over the telephone. 
 
Subjects may be provided participant stipends as agreed upon by Sponsor and the site, and as 
allowed by the site’s standard operating procedures/regulations and the IRB. Stipends amounts 
may cover costs associated with the study participant to complete follow-up visits, but cannot be 
coercive. 
 
9.1.2 
Visit 1: Screening/Preoperative Visit (Baseline, <8 weeks prior to procedure) 
 
Below are the procedures that will be done at the Screening/Preoperative visit. 
 
NOTE: Any subject who signs an informed consent/assent but fails to meet the required entry 
criteria is considered to be a Screen Failure. Screen Failure subjects who are consented but do 
not complete the baseline screening will be assigned a Subject ID number, and their 
demographic information captured in the appropriate CRF and/or log with the reason for screen 
failure specified. 
 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 44 of 94 
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
Commence procedure. 
Complete arthroscopy inclusion/exclusion; if subject is excluded, no further 
information is obtained and the subject is considered a Screen Fail. 
Obtain inter-operative images/videos, if available. 
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and 
device deficiencies. 
Instruct the subject on proper postoperative care/procedures, including any 
contraindicated treatments/medication(s). 
1. 
2. 
3. 
4. 
5. 
6. 
 
 
 
9.1.3 
Visit 2: Operation Visit (Procedure) 
 
2. 
Obtain demographic information and medical history, including information on all 
concomitant medications/concomitant therapies. 
3. 
Screen the subject for protocol inclusion/exclusion criteria. 
4. 
Assign the subject a study ID number and instruct the subject on treatment procedures. 
5. 
Obtain baseline radiographs. 
6. 
Obtain baseline MRI. 
7. 
Obtain baseline PROs: KOOS, IKDC Subjective, and Lysholm. 
8. 
Obtain baseline EQ-5D-5L CRF. 
9. 
Subjects will be instructed to return for the Operation Visit (Procedure) as scheduled by 
the site. 
10. 
If applicable, complete an End of Study CRF. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 45 of 94 
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and 
device deficiencies. 
Instruct the subject on follow-up procedures, including returning the site for a FU visit 
at 3 months. 
If applicable, complete an End of Study CRF. 
1. 
2. 
3. 
4. 
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and 
device deficiencies. 
Instruct the subject on follow-up procedures, including returning the site for FU visit 
at 6 months. 
If applicable, complete an End of Study CRF. 
1. 
2. 
3. 
4. 
 
 
 
9.1.4 
Visit 3: Safety Follow-Up (7-15 days after procedure) 
 
 
9.1.5 
Visit 4: 3-Month Follow-Up (90 days after procedure +/- 14 days) 
 
Instruct the subject on follow-up procedures, including returning the site for follow-up 
(FU) Visit 1 in 7-15 days. 
Complete Details of Surgery Procedure CRF. 
Complete Details of Pathology CRF. 
Complete Details of Post-Operative Plan CRF. 
If applicable, complete an End of Study CRF. 
7. 
8. 
9. 
10. 
11. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 46 of 94 
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
Complete Review Post-Operative Plan/Return to Work CRF. 
Obtain 6-month PROs: KOOS, IKDC Subjective, and Lysholm. 
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and 
device deficiencies. 
Obtain in-office needle endoscopy, if available. 
Instruct the subject on follow-up procedures, including returning the site FU visit at 
12 months. 
If applicable, complete an End of Study CRF. 
1. 
2. 
3. 
4. 
5. 
6. 
7. 
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
Obtain 12-month PROs: KOOS, IKDC Subjective, and Lysholm. 
Obtain 12-month EQ-5D-5L CRF. 
Obtain 12-month Patient Satisfaction CRF. 
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and 
device deficiencies. 
Obtain 12-month MRI. 
Instruct the subject on follow-up procedures, including returning the site for FU visit 
at 24 months. 
If applicable, complete an End of Study CRF. 
1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
 
9.1.6 
Visit 5: 6-Month Follow-Up (185 days after procedure +/-30 days) 
 
 
9.1.7 
Visit 6: 12-Month Follow-Up (365 days after procedure +/-60 days) 
 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 47 of 94 
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
Obtain 24-month PROs: KOOS, IKDC Subjective, and Lysholm. 
Obtain 24-month EQ-5D-5L CRF. 
Obtain 24-month Patient Satisfaction CRF. 
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and 
device deficiencies. 
Obtain 24-month radiographs. 
Obtain 24-month MRI. 
Complete an End of Study CRF. 
1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
 
9.1.8 
Visit 7: Exit Visit / 24-Month Follow-Up (730 days after procedure +/-60 days) 
 
 
9.1.9 
Reoperations 
 
Any reoperations of the study knee will be captured in the source documents and on the 
Reoperation CRF. Details of the reoperation will be captured, including the reason for the 
reoperation. At the reoperation, use of any concomitant medications, concomitant therapies, 
adverse events, and device deficiencies will be collected. As applicable, the study implant 
disposition will be obtained. 
 
9.1.10 
Unscheduled Visits 
 
Any unscheduled visits of the study knee will be captured in the source documents and on the 
Unscheduled Visit CRF. At the visit, general health, use of any concomitant medications, 
adverse events, and device deficiencies will be collected. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 48 of 94 
 
9.1.11 
Concomitant Medications and Concomitant Therapies 
 
Concomitant medications and concomitant therapies (e.g., physical therapy, TENS Unit, 
massage) are recorded at any time from enrollment into the study through the subject’s last 
study visit. 
 
9.1.11.1 
Concomitant Medications 
 
9.1.11.1.1 
Excluded Concomitant Medications 
 
Any individual who is on immunosuppressive therapy at screening is ineligible for the study. If a 
subject starts immunosuppressive therapy during the study, they will be withdrawn from the 
study. There are no other medication restrictions for this study. 
 
9.1.11.1.2 
Recording Concomitant Medications in the CRF 
 
All medications that the subject is on will be recorded in the CRF. The CRF Completion 
Guidelines will stipulate how medications should be recorded in the CRF. 
 
9.1.11.2 
Concomitant Therapies 
 
9.1.11.2.1 
Therapies Prohibited During the Study 
 
For this study there are no restrictions on concomitant therapies. 
 
9.1.11.2.2 
Recording Concomitant Therapies in the CRF 
 
Concomitant therapies should be recorded on the designated CRF. Reference the CRF 
Completion Guidelines for how concomitant therapies are recorded. 
 
9.1.12 
Discontinued Subjects 
 
Discontinued subjects are those who voluntarily discontinue participation, who are withdrawn for 
reasons of safety or use of prohibited concomitant medications, who are lost to follow-up, or who 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 49 of 94 
 
have missed 2 consecutive follow-up visits, or fail to complete the procedure at baseline so are 
ineligible for further participation; refer to section 7.8 for further details. Where possible, a full 
Exit Visit should be completed for all subjects who discontinue the study early. Where consent is 
withdrawn, the date and any reason given for discontinuation should be captured, at a minimum 
(see Section 7.8.2). 
 
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or 
procedures necessary for their medical condition. Medical care will not be provided to the 
subject after the clinical investigation is completed, other than the standard care provided by the 
site, which is not considered a study visit(s). 
 
9.1.13 
Subject Pregnancy 
 
Women of child-bearing potential are not excluded from the study as long as adequate birth 
control methods are being used by the subject as outlined in the protocol’s exclusion criteria. 
However, if a woman becomes pregnant during the study, S+N must be contacted immediately 
once the investigator is made aware of the pregnancy and a decision will be made regarding the 
continuation in the study of the pregnant woman. Pregnancy is not an adverse event; however, 
complications related to the pregnancy may be reportable as determined on a case-by-case 
basis. Pregnancy-related information will be collected until the end of the pregnancy or the end 
of the study. 
 
9.2 
STUDY METHODS AND MEASUREMENTS 
 
The following methods and measurements will be used for this study: 
 
• 
Radiographs 
• 
Magnetic Resonance Imaging (MRI) 
• 
Inter-operative images/videos 
• 
KOOS 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 50 of 94 
 
• 
IKDC Subjective 
• 
Lysholm 
• 
In-office needle endoscopy 
• 
Health Economics/Quality of Life 
 
9.2.1 
Radiographs 
 
Radiography is an imaging technique using X-rays, gamma rays, or similar ionizing radiation and 
non-ionizing radiation to view the internal form of an object.29 For this study, radiographs will 
include x-ray images of the treatment knee. Radiographs will be obtained at baseline and 2 
years post-treatment to assess cartilage signal and joint space narrowing (JSN). Sites will make 
arrangements for radiographs per standard procedures and provide the images/results to the 
Sponsor. 
 
9.2.2 
Magnetic Resonance Imaging (MRI) 
 
Magnetic Resonance Imaging (MRI) is a medical imaging technique that uses magnetic field and 
computer-generated radio waves to create detailed images of an organ or tissue in the body.30 
For this study, MRIs will be obtained at baseline, and 1 and 2 years post-treatment to assess 
structural integrity and healing. Sites will make arrangements for MRIs per standard procedures 
and provide the images/results to the Sponsor. 
 
9.2.3 
Inter-operative Images/Video 
 
Inter-operative images are pictures and videos that are taken during a procedure using a small 
camera inserted into the body during treatment. In this study, inter-operative images and videos 
will be taken if available during the meniscal repair to obtain information regarding surgical 
technique and can be used, if necessary, to assess the cause of any adverse events. Sites will 
use their own equipment to take inter-operative images/videos and provide to Sponsor. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 51 of 94 
 
9.2.4 
Knee Injury and Osteoarthritis Outcome Score (KOOS) 
 
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a validated Patient Reported 
Outcome measurement tool. The KOOS was developed in the 1990s as an instrument to assess 
the patient’s opinion about their knee and associated problems. Since it was first published in 
1998, the psychometric properties of the KOOS have been assessment in more than twenty 
individual studies from all over the world, as well as being compared to other instruments in 
multiple reviews. The instrument has been validated for consequences in different populations 
with varying diseases and durations and at varying ages and activity levels.31,32,33 
 
There are five patient-relevant subscales of the KOOS, and each are scored separately: 
 
• 
Pain (9 items) 
• 
Symptoms (7 items) 
• 
ADL function (17 items) 
• 
Sport and Recreation Function (5 items) 
• 
Quality of Life (4 items) 
 
A Likert scale is used and all items have five possible answer options scored from 0 (no 
problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items 
included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee 
problems and 100 representing no knee problems as common in orthopedic assessment scales 
and generic measures. An aggregate score is not calculated so that each of the 5 dimensions 
can be assess separately.31,32 
 
9.2.5 
International Knee Documentation Committee (IKDC) Subjective 
 
The International Knee Documentation Committee (IKDC) Subjective score was developed to 
detect improvement or deterioration in symptoms, function, and sports activities due to knee 
impairment, including patients with meniscal injuries. The original IKDC form was published in 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 52 of 94 
 
1993, and there were several revisions up to the current version published in 2001. This is a 
validated questionnaire if it is completed by the patient; it takes the patient about 10 minutes to 
complete.32 
 
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and 
giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and 
knee function prior to knee injury (1 item, not included in the score). Responses vary for each 
item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting 
activities and the absence of symptoms. The normative data for the score are available for the 
general US population, stratified for age, gender, and current/prior knee problems.32 
 
9.2.6 
Lysholm 
 
The Lysholm scale was first introduced into the medical community in 1982, and modified in 
1985, and is a validated patient or physician administered instrument to measure symptoms and 
function in patients in patients with a variety of knee injuries. This tool measures the domains of 
symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is 
scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of 
functioning.33,34 
 
9.2.7 
In-Office Needle Endoscopy 
 
In-office needle endoscopy is a minimally invasive procedure in which a needle-sized camera is 
inserted into tissue for observation and/or biopsy purposes. For this study, a needle-sized 
endoscopy will be inserted to record video and images of the meniscal repair site and visually 
assess healing. This will be performed on up to 30 subjects (up to 15 HCT and up to 15 complex 
meniscal tears) at sites that are able to conduct this type of imaging using existing equipment. 
 
9.3 
HEALTH ECONOMICS/QUALITY OF LIFE 
 
Following secondary outcomes will be collected: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 53 of 94 
 
1. 
Employment status pre-surgery: Currently working/employed category ) and job 
type. 
 
2. 
Nature of work: Laborer/Sedentary work (Sedentary deined as “involves 
occasional lifting of no more than ten pounds and sitting with occasional walking 
and standing”). 
 
3. 
Return to work after surgery (Days) and type of work. 
 
4. 
Patient Satisfaction at 1 year and 2 years. 
 
5. 
EQ-5D-5L will be used to derive general health-related QoL scores at baseline, 1 
year, and 2 years. The EQ-5D-5L descriptive system comprises the following 
dimensions: Mobility, Self-Care, Usual Pain / Discomfort and Anxiety/ Depression. 
Each dimension has 5 levels: no problems, slight problems, moderate problems, 
severe problems, and extreme problems. The tool is widely used in cost- 
effectivess analysis and is available in a variety of languages.35 
 
STATISTICAL DESIGN 
 
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The 
following is a brief description of the analyses to be described in this plan. 
 
10.1 
GENERAL 
 
Smith + Nephew’s Global Biostatistics group or designee will conduct the statistical analysis for 
this study. Unless otherwise stated, all significance tests will be two-sided, performed at the 5% 
significance level. Resulting p-values will be quoted. Point estimates and their corresponding 
95% two-sided confidence intervals will be generated where appropriate. Where data summaries 
are specified, categorical or ordinal variables will be summarized with frequencies and 
percentages. Continuous variables will be summarized with the following summary statistics: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 54 of 94 
 
number of observations, mean, median, standard deviation, minimum and maximum values. All 
analyses will be performed in SAS 9.4 (or later). 
 
10.2 
ANALYSIS POPULATIONS 
 
The following analysis populations will be used for this study: 
 
• 
Full Analysis Set (FAS), following Intention to Treat principle including all subjects who 
were recruited into the study and attended at least one post-surgery assessment. 
• 
Safety Population (SAF), including all subjects who have received the study device. 
• 
Per-Protocol Population (PP), including all subjects in the full analysis set who have no 
significant protocol deviations and met the inclusion/exclusion criteria. 
 
Statistical analysis will be performed using each of the patient populations as follows: analysis of 
primary and secondary endpoints will be performed separately using both the FAS and PP 
populations. All safety analyses will utilize the SAF population. 
 
10.3 
BASELINE DATA 
 
Data to be summarized at baseline includes, but is not limited to, all collected demographic 
variables such as age, gender, BMI, primary diagnosis and medical history. The baseline 
variables will be used to describe the outcome data where necessary. 
 
10.4 
EFFICACY ANALYSIS 
 
10.4.1 
Analysis of Primary Endpoint 
 
A binary variable will be defined for whether each patient had reoperation due to meniscal repair 
failure for all treatment visits. This variable will be used to present the proportion of reoperation 
due to meniscal repair failure at 12 months, together with a percentage and 95% confidence 
interval for a single proportion (calculated using the Clopper-Pearson method).36 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 55 of 94 
 
The following hypotheses will be tested to establish that the rate of reoperation of the 
NOVOSTITCH PRO is strictly no worse (lower) than the literature derived value: 
 
H0: μ - μ0 ≤ 0 
Ha: μ - μ0 > 0 
In the stated hypthothesis, µ represents the rate of reoperation for the NOVOSTITCH PRO and 
µ0 represents the literature derived value (80%).24 A one sided t-test with alpha = 0.025 will be 
used to evaluate the hypothesis and the corresponding 95% CIs will also be presented. 
 
Analysis will be carried out using the FAS population as the primary analysis population with the 
PP population used for sensitivity analysis. 
 
10.4.2 
Analysis of Secondary Endpoint(s) 
 
The following secondary endpoints will be analyzed for this study. 
 
• 
Rate of reoperation due to meniscal repair failure at 6 and 24 months post-operative will 
be summarized using frequency and percentage. A 95% exact confidence interval for the 
percentage will also be presented using the Clopper-Pearson method.36 
• 
Analysis of MRI of structural integrity of meniscus at baseline, 12 months and 24 months 
will be conducted separately by an imaging vendor. The change in meniscal signal 
between baseline and 1 and 2 years will be summarized. 
• 
Analysis of radiographs to evaluate tibiofemoral joint space narrowing (JSN) at baseline 
and 24 months will be conducted separately by an imaging vendor. The change in cartilage 
signal and joint space narrowing as indicators of osteoarthritis on X-rays taken baseline vs 
at 2 years will be summarized. 
• 
Results of in-office needle endoscopy of healing at the repair site at 6 months will be 
presented by frequency and percentage. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 56 of 94 
 
• 
IKDC Subjective, KOOS & Lysholm PRO scores will be calculated and summarized for 
each visit appropriately for categorical or continuous variables. Change from baseline 
score to each post-operative visit (6, 12 and 24 months) score will be presented. For 
Lysholm and IKDC Subjective, the numbers and proportions of subjects, together with a 
95% confidence interval (calculated using the Clopper-Pearson Exact method)36, meeting 
the minimal clinically important differences (MCID) from baseline to appropriate post- 
operative visit (those which have MCID thresholds available in published literature) will 
be presented. 
 
10.4.3 
Analysis of Other Endpoint(s) 
 
• 
Patient Satisfaction and EQ-5D-5L results will be summarized for each visit appropriately 
for categorical or continuous variables. Any open-ended questions will be presented as a 
listing. 
• 
Multivariate analysis of demographic and procedural predictors on rate of reoperation, 
improvement in PROs or attaining MCID thresholds will be presented. Variables of 
interest are; age, complex tear orientation, hybrid vs non-hybrid approach, types of 
devices used with NOVOSTITCH PRO and other patient demographics. 
• 
Rate of reoperation, PRO scores and healing status will be presented by tear type 
(complex and HCTs). 
• 
The number and proportion of subjects experiencing device deficiencies where 
NOVOCUT Suture Manager has been used alongside the NOVOSTITCH PRO with a 
95% confidence interval (calculated using the Clopper-Pearson Exact method)36. 
 
10.5 
SAFETY ANALYSES 
 
All safety endpoints will be summarized using the safety population. 
Adverse Events 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 57 of 94 
 
The number of subjects reporting: adverse events, serious adverse events, severe adverse 
events, device-related adverse events, serious device-related adverse events, unanticipated 
adverse events, and serious unanticipated adverse events will be summarized. In addition, for 
each adverse event, the following will be summarized: severity, the relationship to the 
investigational device, outcome and duration of the resolved adverse events and the duration of 
the adverse events at trial discontinuation. 
 
Device deficiencies 
 
The number of device deficiencies and the number of patients reporting a device deficiency will 
be summarized. 
 
Additional summaries of safety endpoints, if applicable, will be described in the SAP. 
 
10.6 
INTERIM ANALYSES 
 
There are no formal interim analyses planned for this study, however Clinical Activity Reports 
(CAR) may be produced to faciliate the publication of the results (in part of in whole) for scientific 
conferences and publications. Additional adhoc analyses may occur as needed (e.g. for 
abstracts or publications). 
 
SAMPLE SIZE JUSTIFICATION 
 
The sample size for this study is precision-based, and not based on statistical power 
considerations, thus no formal statistical hypothesis is formulated. The sample size for this study 
is determined based on the feasibility of recruitment, enrollment and follow-up considerations. 
 
With an estimated clinical success rate of 80% at 12 months for the planned study, the 95% 
confidence interval for clinical success was calculated between 70% and 90%. Using an 84% 
success rate, the minimum enrollment is N=71. With an attrition rate of 10% per year, total 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 58 of 94 
 
enrollment is set to N=90; a minimum of N=40 horizontal cleavage tears and N=40 complex 
tears. 
 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
12.1 
DEFINITIONS 
 
The categories of adverse events are shown in table 12.1-1. The definitions for each of these 
categories are given in the subsequent sections. 
 
Table 12.1-1: Categories of Adverse Event 
 
NOT DEVICE- 
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON- 
SERIOUS 
ADVERSE EVENT 
(AE) 
ADVERSE DEVICE EFFECT 
(ADE) 
SERIOUS 
SERIOUS ADVERSE 
EVENT 
(SAE) 
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) (SEE 12.1.3) 
ANTICIPATED 
UNANTICIPATED 
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT 
(ASADE) 
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT 
(USADE) 
 
12.1.1 
Adverse Event 
 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease of untoward 
clinical sign (including abnormal laboratory findings) in subjects, users or other persons, whether 
or not causally related to the IP. 
 
Note 1: This definition includes events related to the IP. 
 
Note 2: This definition includes events related to the procedures involved. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 59 of 94 
 
Note 3: For users or other persons, this definition is restricted to events related to the IP. 
 
An AE is used both to refer to AE which do not meet the definitions of Adverse Device Effects or 
Serious Adverse Events and as an umbrella term referring to adverse events of all 
classifications. 
 
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory 
finding), symptom, or disease. For reporting purposes, emphasis is placed first and foremost on 
whether or not the event constitutes an untoward medical occurrence. 
 
12.1.2 
Adverse Device Effect 
 
An Adverse Device Effect (ADE) is an adverse event that, in the opinion of the investigator, is 
related to the use of the IP. 
 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation or operation, or any malfunction of the 
investigational medical device. 
 
Note 2: This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
 
Not Related - An AE is considered to be not related to the use of an Investigational Product (IP) 
or the procedure when the effect is DEFINITELY UNRELATED or UNLIKELY to 
have any relationship to the use of the IP or the procedure; 
 
Related – An AE is considered to be related to the use of an IP or the procedure when there is 
a POSSIBLE, PROBABLE, or DEFINITE relationship between the AE and the use of 
the IP or the procedure. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 60 of 94 
 
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 are 
met. 
 
12.1.3 
Serious Adverse Events and Serious Adverse Device Effects 
 
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effects 
(SADE) if, in the view of either the Investigator or the Sponsor, it: 
• 
a) led to death, 
• 
b) led to serious deterioration in the health of the subject, that either resulted in 
o 
1) a life-threatening illness or injury, or 
o 
2) a permanent impairment of a body structure or a body function, or 
o 
3) in-patient or prolonged hospitalization, or 
o 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
• 
c) led to fetal distress, fetal death or a congenital abnormality or birth defect 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the study 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
 
12.1.4 
Anticipated/Unanticipated Serious Adverse Device Effect 
 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk analysis 
report. 
 
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
 
Anticipated device effects include the following: 
 
• 
Suture deployed prematurely; 
• 
Handle does not fully retract; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 61 of 94 
 
• 
Lower jaw does not retract; 
• 
Distal or central miss in which the suture does not go through the meniscus; 
• 
Suture cartridge not loaded properly / suture cartridge not in track; 
• 
Suture drop from the upper jaw where the suture pulls out of the meniscus. 
 
12.1.5 
Severity 
 
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the 
responsibility has been delegated and documented on the delegation of authority log. An AE 
should be classified as mild, moderate, or severe, regardless of whether or not the AE is 
considered to be serious or non-serious. The classification should be based on the following 
definitions: 
 
Mild - 
An event is mild if the subject is aware of, but can easily tolerate the sign or 
symptom; 
 
Moderate - 
An event is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities; 
 
Severe - 
An event is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
 
12.1.6 
Device Deficiency 
 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. A DD includes malfunctions, use errors and 
inadequate labeling. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 62 of 94 
 
12.2 
AE CODING DICTIONARY 
 
Coding for this study will be done per International Medical Device Regulators Forum (IMDRF) 
AE Terminology Annex F – Clinical signs, symptoms and conditions. 
 
12.3 
REPORTING PROCEDURES 
 
AEs of any kind and DDs will be recorded in the applicable CRF and source notes. The 
Investigator will evaluate all AEs for relationship to the device and procedure, if applicable, 
seriousness, and severity. The following timescales should be followed for the AE/DD 
information to be entered into the CRF and reported to the Sponsor or designee (see figure 
12.2-1): 
 
• 
ADE and DD – without unreasonable delay 
• 
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 hours of 
the investigator being informed about the event) 
 
For ADEs and DDs, details of the product/procedure related to the event will be included and 
where applicable, pictures taken of the device. The deficient product should be retained for 
return to S+N unless it is contaminated (e.g., used dressings must not be retained). Updates to 
submitted information will be recorded in the CRF according to the timescales above. 
 
All adverse events will be reviewed by a medically qualified person appointed by the Sponsor to 
determine which, if any, meet criteria for expedited reporting to the regulatory authorities. 
 
The investigator will inform the IRB of adverse events according to the IRB requirements. 
 
Depending on the nature of the adverse event, S+N may request copies of the subject’s medical 
records, Imaging, Operative notes, as well as results of any relevant laboratory tests performed 
or other documentation related to the AE. If the subject was hospitalized, a copy of the 
discharge summary may be requested by S+N and should be forwarded as soon as it becomes 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 63 of 94 
 
available. In certain cases, S+N also may request a letter from the Investigator that summarizes 
the events related to the case. Refer to the Investigator Site File (ISF) Sponsor Contact 
Information Sheet to report SAE, unanticipated ADE and SADE, anticipated SADE, and DD. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 64 of 94 
Record 
details in 
subject s 
medical 
records 
Record 
information in 
patient CRF 
according to 
usual 
timescales. 
Complete CRF 
and alert S&N 
without 
unreasonable 
delay. 
Serious Adverse 
Event (SAE) 
Anticipated 
Serious Adverse 
Device Effect 
(ASADE) 
Complete CRF 
and alert S&N 
IMMEDIATELY 
Unanticpated 
Serious Adverse 
Device Effect 
(USADE) 
unanticipated 
Related 
Investigator 
assesses whether 
SADE is 
anticipated 
Investigator 
assesses device 
relationship 
Serious 
Not Related 
Site 
aware 
of AE 
Investigator 
assesses 
seriousness 
Non-serious 
Related 
Investigator 
assesses device 
relationship 
Not Related 
Adverse Device 
Effect (ADE) 
Adverse Event 
(AE) 
 
Figure 12.3-1: Evaluation and Reporting of AE 
 
 
 
 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 65 of 94 
 
 
 
 
 
Potential to cause SADE 
 
 
 
 
Site aware 
  
                 
of DD 
Investigator 
assesses whether 
could have led to 
SADE 
 
Record details in subject s 
medical records 
 
 
No potential to cause SADE 
 
 
 
 
 
12.4 
UNBLINDING OF INVESTIGATIONAL PRODUCT 
 
Not applicable. 
 
12.5 
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS 
 
For subjects who are experiencing ongoing unresolved AE at the time of their study completion 
or early discontinuation from the study, it is recommended that the Investigator schedule an 
appropriate follow-up visit to determine the outcome of the event. 
 
Any additional data must be documented and available to the Sponsor who will determine 
whether the data need to be documented in the CRF, and as required, the Clinical Study Report. 
 
12.5.1 
Ongoing Adverse Events at Study Discontinuation 
 
Adverse events which are related to a study procedure or S+N IP and are ongoing at the end of 
subject’s participation: The event should be followed until it is either resolved or until the event 
Record information in patient 
CRF according to usual 
timescales. 
Complete CRF and alert S&N 
IMMEDIATELY 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 66 of 94 
 
has become chronic and is not expected to further improve based on Investigator’s review of the 
event. 
 
Adverse events which are not related to a study procedure or S+N IP and are ongoing at the 
end of subject’s participation should be followed for 30 days after discontinuation or if the AE is 
resolved, whichever is sooner. 
 
At the time of data analysis (e.g., interim or final), an evaluation of ongoing events should take 
place and be listed as ongoing in the safety table. 
 
INVESTIGATOR OBLIGATIONS 
 
The Principal Investigator will comply with the commitments outlined in the in the Statement of 
Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Appendix 21.7 of this protocol. 
 
In addition, the PI will ensure that the Financial Disclosure Statements will be completed by the 
PI and the Sub-Investigator upon entry into the study and as any changes that affect their 
financial disclosure status occur during the course of the study and up to one year after study 
completion. 
 
SPONSOR AND MONITOR RESPONSIBILITIES 
 
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored to ensure that: the rights and wellbeing of 
the subjects are protected; the reported data are accurate, complete, and verifiable from the 
source documents; and the study is conducted in compliance with the currently approved 
protocol and amendment(s), if applicable, with GCP regulations, and with applicable regulatory 
requirements. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 67 of 94 
 
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan for this 
study. 
 
14.1 
SITE QUALIFICATION VISIT 
 
A site qualification visit will be performed by the Sponsor prior to the execution of a clinical 
agreement to ensure that all Investigators have the appropriate training, staff, facilities, and 
resources to adequately conduct the study. 
 
14.2 
SITE INITIATION VISIT 
 
A site initiation visit to provide training on the specifics of the study, site obligations and 
expectations of study conduct will be performed by the Sponsor or qualified person designated 
by the Sponsor following the execution of the CTA and documented IRB approval. 
 
14.3 
SPONSOR AUDITS AND REGULATORY INSPECTION 
 
Quality Assurance auditors, whether an employee of the Sponsor or its designee, may evaluate 
study conduct at the study sites. These parties must have access to any and all study reports 
and source documentation, regardless of location and format. 
 
14.4 
CLOSE-OUT VISIT 
 
A study close-out visit will be performed by the Sponsor or designee to retrieve and account for 
all remaining clinical data and to resolve outstanding queries. During study close-out, the 
monitor will review investigator files to ensure required documents and records are on file, 
confirm the disposition of any other ancillary items used for the study, and review regulatory 
requirements regarding records retention and IRB reporting requirements. When no subjects 
have been included, a remote close-out visit may be conducted. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 68 of 94 
 
PROTOCOL AMENDMENTS 
 
Amendments should be made only in necessary cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB. 
Protocol amendments need to be approved by the IRB according to the applicable requirements 
prior to implementation at the site. 
 
CONFIDENTIALITY OF THE STUDY 
 
The confidentiality of this study and associated documents is governed by the terms of the 
Clinical Trial Agreement (CTA). 
 
STATEMENTS OF COMPLIANCE 
 
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; ISO 14155: Clinical investigation of medical devices – Good Clinical Practice; and any 
local regulations. 
 
This clinical study will not commence until the required approval/favorable opinion from the IRB 
or regulatory authority has been obtained. Any additional requirements imposed by the IRB or 
regulatory authority will be followed. 
 
END OF STUDY 
 
The end of study is considered the last visit of the last subject undergoing treatment in the study. 
It is expected that this study will last 42 months total. 
 
Should circumstances arise which require the termination of the entire study prior to its planned 
completion (e.g., safety concerns) or circumstances arise which mean the end of the 
participation of an individual site (e.g., departure of Investigator, non-compliance), then this will 
be undertaken according to the SOPs of the Sponsor. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 69 of 94 
 
An End of Study CRF needs to be completed for any subject that does not complete the study, 
to document the reason for termination. 
 
The entire study may be terminated if deemed necessary by the Sponsor (e.g. the product is 
determined to not be safe). Sites may be terminated for reasons that include, but are not limited 
to non-compliance to the protocol, ethical violations, or inability to recruit subjects. 
 
PUBLICATION POLICY 
 
19.1 
PUBLICATION OF STUDY DATA 
 
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the Health Insurance 
Portability and Accountability Act of 1996. 
 
19.2 
DATA SHARING 
 
Smith + Nephew, Inc. (S+N) is committed to upholding the highest ethical and legal standards 
involved in conducting clinical trials. S+N, therefore, supports the data sharing requirements of 
The International Committee of Medical Journal Editors (ICMJE) published on the 6th June 
2017. In accordance, S+N will consider requests to share individual (de-identified) participant 
data that underlie the results of any interventional clinical trial, as presented from the 1st July 
2018 within an ICMJE associated journal. Requests made by researchers who provide a 
methodologically sound proposal will be considered. Requests may include data that underlie 
results presented in text, tables, figures, and appendices, together with data dictionaries. 
Availability of these data will begin nine months and end 36 months after article publication. Data 
supplied may only be used by the researcher(s) named in the approved research proposal for 
the purposes of achieving the aims of the analyses specified therein. All proposals should be 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 70 of 94 
 
directed to the Sponsor. To gain access, data requestors will need to sign a data access 
agreement. 
 
REFERENCES 
 
1. Scotti C, Hirschmann MT, Antinolfi P, Martin I, Peretti GM. Meniscus repair and regeneration: 
review on current methods and research potential. European cells & materials. 2013;26:150- 
170. 
 
2. VanderHave KL, Perkins C, Le M. Weightbearing Versus Nonweightbearing After Meniscus 
Repair. Sports health. 2015;7(5):399-402. 
 
3. Monk P, Garfjeld Roberts P, Palmer AJ, et al. The Urgent Need for Evidence in Arthroscopic 
Meniscal Surgery. Am J Sports Med. 2017;45(4):965-973. 
 
4. Rothermel SD, Smuin D, Dhawan A. Are Outcomes After Meniscal Repair Age Dependent? A 
Systematic Review. Arthroscopy. 2018;34(3):979-987. 
 
5. Xu C, Zhao J. A meta-analysis comparing meniscal repair with meniscectomy in the treatment 
of meniscal tears: the more meniscus, the better outcome? Knee surgery, sports traumatology, 
arthroscopy : official journal of the ESSKA. 2015;23(1):164-170. 
 
6. Mehl J, Otto A, Baldino JB, et al. The ACL-deficient knee and the prevalence of meniscus and 
cartilage lesions: a systematic review and meta-analysis (CRD42017076897). Arch Orthop 
Trauma Surg. 2019;139(6):819-841. 
 
7. Mezhov V, Teichtahl AJ, Strasser R, Wluka AE, Cicuttini FM. Meniscal pathology - the 
evidence for treatment. Arthritis research & therapy. 2014;16(2):206. 
 
8. Hutchinson ID, Moran CJ, Potter HG, Warren RF, Rodeo SA. Restoration of the meniscus: 
form and function. Am J Sports Med. 2014;42(4):987-998. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 71 of 94 
 
9. Laible C, Stein DA, Kiridly DN. Meniscal repair. The Journal of the American Academy of 
Orthopaedic Surgeons. 2013;21(4):204-213. 
 
10. Kurzweil PR, Lynch NM, Coleman S, Kearney B. Repair of horizontal meniscus tears: a 
systematic review. Arthroscopy. 2014;30(11):1513-1519. 
 
11. Feeley BT, Lau BC. Biomechanics and Clinical Outcomes of Partial Meniscectomy. The 
Journal of the American Academy of Orthopaedic Surgeons. 2018;26(24):853-863. 
 
12. Kim JG, Lee SY, Chay S, Lim HC, Bae JH. Arthroscopic meniscectomy for medial meniscus 
horizontal cleavage tears in patients under age 45. Knee Surg Relat Res 2016;28: 225-232. 
 
13. Haemer JM, Wang MJ, Carter DR, Giori NJ. Benefit of single-leaf resection for horizontal 
meniscus tear. Clin Orthop Relat Res 2007;457:194-202. 
 
14. Zhang AL, Kelly NH, et al., Tibiofemoral contact pressures in radial tears of the meniscus 
treated with all-inside repair, inside-out repair and partial meniscectomy,” The Knee, vol. 22, no. 
5, pp. 400-404, 2015. 
 
15. Logerstedt D, Snyder-Mackler L. Knee pain and mobility impairments: meniscal and articular 
lesions. J Orthop Sports Phys Ther. 2010 June ; 40(6): A1–A35.) 
 
16. Blackmore SA, McGee AW, Jr., Gladstone JN, Strauss EJ, Davidson PA, Jazrawi LM. The 
management of meniscal pathology: from partial meniscectomy to transplantation. Instructional 
course lectures. 2015;64:511-520. 
 
17. Westermann RW, Duchman KR, Amendola A, Glass N, Wolf BR. All-Inside Versus Inside- 
Out Meniscal Repair With Concurrent Anterior Cruciate Ligament Reconstruction: A Meta- 
regression Analysis. Am J Sports Med. 2017;45(3):719-724. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 72 of 94 
 
18. Kim YM, Joo YB, Noh C, Park Il. The Optimal Suture Site for the Repair of Posterior Horn 
Root Tears: Biomechanical Evaluation of Pullout Strength in Porcine Menisci. KSRR. 2016; 
28(2):147-152. 
 
19. Beamer B, Walley K, Okajima S, et al. Changes in Contact Area in Meniscus Horizontal 
Cleavage Tears Subjected to Repair and Resection. Arthroscopy. 2017; 33(3):617-624. 
 
20. Beamer B, Masoudi A, Walley K, et al. Analysis of a New All-Inside Versus Inside-Out 
Technique for Repairing Radial Meniscal Tears. Arthroscopy. 2015; 31(2):293-8. 
 
21. J. D. Saliman, “The circumferential compression stitch for meniscus repair,” Arthroscopy 
Techniques, vol. 2, no. 3, pp. e257–e264, 2013. 
 
22. A. J. Blackman, M. J. Stuart, B. A. Levy, M. A. McCarthy, A. J. Krych, “Arthroscopic meniscal 
root repair using a Ceterix Novostitch suture passer,” Arthroscopy Techniques, vol. 3, no. 5, pp. 
e643–e646, 2014. 
 
23. O'Donnell K, Freedman KB, Tjoumakaris FP. Rehabilitation Protocols After Isolated Meniscal 
Repair: A Systematic Review. Am J Sports Med. 2017;45(7):1687-1697. 
 
24. Rubman MH, Noyes FR, Barber-Westin SD (1998) Arthroscopic repair of meniscal tears that 
extend into the avascular zone. A review of 198 single and complex tears. Am J Sports Med 
26(1):87–95CrossRefGoogle Scholar 
 
25. Smith J, Dougherty C. Early Results of All-Inside, All-Suture Circumferential Compression 
Stitch Meniscal Repairs. Unpublished Manuscript. 
 
26. Kurzweil P, Krych A, Anz A, et al. Does Repair of Horizontal Cleavage Meniscus Tears 
Improve Patient Outcomes? 1 Year Results from Prospective Multi-Center STITCH Trial. ICRS 
Abstract. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 73 of 94 
 
27. Pujol N, Salle De Chou E, Boisrenoult P, Beaufils P. “Platelet-rich plasma for open meniscal 
repair in young patients: any benefit?,” Knee Surgery, Sports Traumatology, Arthroscopy, vol. 
23, no. 1, pp. 51–58, 2015. 
 
28. Chung KS, Ha JK, Yeom CH, et al., “Comparison of clinical and radiologic results between 
partial meniscectomy and refixation of medial meniscus posterior root tears: a minimum 5-year 
follow-up,” Arthroscopy: The Journal of Arthroscopic & Related Surgery, vol. 31, no. 10, pp. 
1941–1950, 2015.8. 
 
29. Radiography [Internet]. Wikipedia [updated 2020 Feb 12, cited 2020 Feb 12] Available from: 
https://en.wikipedia.org/wiki/Radiography 
 
30. MRI [Internet]. Mayo Clinic [updated 2019 Aug 3, cited 2020 Feb 6] Available from: 
https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768 
 
31. Knee Injury and Osteoarthritis Outcome Score [Internet]. Physiopedia. [updated 2020, 
accessed 2020 Feb 6] Available from: 
https://www.physiopedia.com/Knee_Injury_and_Osteoarthritis_Outcome_Score 
 
32. Collins NJ, Misra D, Felson DT, Crossley KM, Roos EW. “Measures of Knee Function,” 
[Internet]. Arthritis Care Res; 2011 Nov [cited 2020 Feb 6] Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336550/ 
 
33. Van Meer BL, Reijman M, et al. [Internet]. In: The Anterior Cruciate Ligament (Second 
Edition). A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate 
Ligament Injured or Reconstructed Patients. 2018. [updated 2020, cited 2020 Feb 6]. Available 
from: https://www.sciencedirect.com/book/9780323389624/the-anterior-cruciate-ligament 
 
34. Barber-Westin SD, Noyes FR. [Internet]. In: Noyes’ Knee Disorders: Surgery, Rehabilitation, 
Clinical Outcomes (Second Edition). Rating of Athletic and Daily Functional Activities. 2017. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 74 of 94 
 
[updated 2020, cited 2020 Feb 6]. Available from: 
https://www.sciencedirect.com/book/9780323329033/noyes-knee-disorders-surgery- 
rehabilitation-clinical-outcomes 
 
35. EQ-5D-5L / About [Internet]. EuroQol [updated 2020, cited 2020 February 26] Available 
from: https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ 
 
36. Clopper, CJ, Pearson ES. In: Biometrika. The use of confidence or fiducial limits illustrated in 
the case of the binomial. 1934, 26 p. 404–413. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 75 of 94 
 
APPENDICES 
 
21.1 
PROTOCOL AMENDMENT 2.0 
 
21.1.1 
General Purpose 
 
The following amendments were made to correct and clarify the protocol. These updates were 
made prior to any IRB submission. This study will start subject enrollment with Protocol Version 
2.0. 
 
21.1.2 
Rationale 
 
The rational for the changes are as follows: 
 
Rationale 1: Correction of errors, changes for consistency in the protocol, and minor 
clarifications. Note that some changes are not listed in the table below (e.g. spelling errors). 
Rationale 2: Clarification of the eligibility criteria, both inclusion and exclusion at screening 
and arthroscopy. The changes were made after receiving feedback on the protocol at Site 
Qualification Visits with PIs, Sub-Investigators, and Study Coordinators. 
Rationale 3: Removed the PROs (KOOS, IKDC Subjective, and Lysholm) from the 3 month 
visit throughout the protocol as these questionnaires are not included in any of the planned 
analysis, and subjects are still recovering from surgery at 3 months. 
Rationale 4: Clarified that the enrollment will be a minimum of 40 subjects per tear type 
rather than 45 of each type as it is not necessary to have exactly 45 of each tear type to 
meet the objectives of the study. 
Rationale 5: Clarified the exploratory endpoint for NOVOCUT to only be assessed during the 
procedure rather than at follow-up as the device is only used during the procedure. 
Rationale 6: Clarified claims and removed claims that are not expected to reach statistical 
significance. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 76 of 94 
 
Rationale 7: Separated the Patient Satisfaction score from the EQ-5D-5L as during 
development of the Case Report Forms, they became independent (the EQ-5D-5L is a 
standard questionnaire and the Patient Satisfaction is only required after the surgery at 1 
and 2 years). 
Rationale 8: Moved and clarified the information regarding how the CRFs are to be 
completed from under Visit 7 to the general section 9.1.1 Summary as this information 
applies to more than just Visit 7. 
 
21.1.3 
Effect on Study Status 
 
Not applicable; this amendment is to be in effect and implemented prior to subject enrollment. 
 
21.1.4 
Details 
 
Section 
Current Text 27/FEB2020 
Version #1.0 
Revised Text 07/APR/2020 Version 
#2.0 
Throughout protocol 
(rationale 1) 
1.0 dated 27/FEB/2020 
2.0 dated 07/APR/2020 
Table of Contents 
(rationale 1) 
Various 
Updated to reflect the current 
sections and page numbers 
Throughout protocol 
(rationale 1) 
EQ-5Q-5L 
EQ-5D-5L 
Throughout protocol 
inclusion criteria 
(rationale 2) 
1. Meniscus to meniscus repair in 
circumferential (zone 1, 2, or 3) 
and/or radial locations (posterior 
or mid-body) 
Text removed 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 77 of 94 
 
Throughout protocol 
inclusion criteria 
(rationale 2) 
3. Tear amenable to repair with 
NOVOSTITCH PRO with or 
without the use of adjunct devices 
per the exclusion criteria. 
1. Meniscal tear amenable to repair 
with NOVOSTITCH PRO with or 
without the use of adjunct devices per 
the exclusion criteria. 
Throughout protocol 
exclusion criteria 
(rationale 2) 
Malalignment of the study knee 
>5 degrees and/or requiring 
osteotomy and/or correction; 
Clinically significant malalignment of 
the study knee, and/or requiring 
osteotomy, and/or correction 
Throughout protocol 
exclusion criteria 
(rationale 2) 
Tears that impinge at 
meniscocapsular junction (ramp 
tears); 
Ramp tears 
Throughout protocol 
exclusion (rationale 
2) 
Physician discretion per the 
Instructions for Use (IFU); 
Text removed 
Throughout protocol 
exclusion (rationale 
2) 
Arthritis in the study knee 
Modified Outerbridge Grade III or 
higher 
Articular cartilage damage in the 
study knee as, defined as by Modified 
Outerbridge Grade III or higher 
Throughout protocol 
PROs 
(rationale 3) 
Removal of PROs at 3-month 
visits 
Text removed 
Throughout protocol 
(rationale 1) 
Meniscus Stitcher 
Meniscal Stitcher 
Throughout protocol 
(rationale 1) 
re-operation 
reoperation 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 78 of 94 
 
2.0 Protocol 
synopsis Exclusion 
(rationale 1) 
13. If material is suspected, 
testing should be completed prior 
to suture implantation; 
14. Conditions which may limited 
the patient’s ability or willingness 
to follow postoperative care 
instructions; 
13. If material sensitivity is suspected, 
testing should be completed prior to 
suture implantation; 
14. Conditions which may limit the 
patient’s ability or willingness to follow 
postoperative care instructions; 
3.4 List of 
Abbreviations 
(rationale 1) 
None 
MCID Minimal Clinically Important 
Difference 
4.2 Literature 
summary (rationale 
1) 
Approximately 30% of all meniscal 
repair failures occur after 2 
years.16 
None 
5.4 Claims 
(rationale 6) 
• 
HCT and Complex repairs 
with NOVOSTITCH PRO 
have a clinical success 
rate of 80% or higher; 
• 
HCT and Complex tears 
repaired with 
NOVOSTITCH PRO have 
reoperation rates similar to 
other commonly repaired 
tear types (<20%); 
• 
HCT and Complex tears 
repaired with 
NOVOSTITCH PRO can 
heal at clinically 
• 
HCT and Complex meniscal 
tears repaired with 
NOVOSTITCH PRO have a 
clinical success rate of 80% or 
higher; 
• 
HCT and Complex meniscal 
tears repaired with 
NOVOSTITCH PRO have 
reoperation rates similar to 
other commonly repaired tear 
types (<20%); 
• 
HCT meniscal tears repaired 
with NOVOSTITCH PRO lead 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 79 of 94 
 
acceptable rates as seen 
on MRI; 
• 
HCT and Complex tears 
repaired with 
NOVOSTITCH PRO can 
heal at clinically 
acceptable rates as seen 
on 2nd look needle 
endoscopy; 
• 
HCT and Complex tear 
repaired with 
NOVOSTITCH PRO lead 
to a significant 
improvement in patient 
symptom scores; 
• 
HCT and Complex tears 
repaired with 
NOVOSTITCH PRO may 
protect the knees against 
joint space narrowing 
(JSN) associated with 
osteoarthritis; 
• 
Patients with HCT and 
Complex tears repaired 
with NOVOSTITCH PRO 
are able to return to work 
within 6 months; and 
to a significant improvement in 
patient symptom scores; and 
• 
Complex meniscal tears 
repaired with NOVOSTITCH 
PRO lead to a significant 
improvement in patient 
symptom scores; 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 80 of 94 
 
• 
Patients with HCT and 
Complex tears repaired 
with NOVOSTITCH PRO 
have significant 
improvements in Quality of 
Life (EQ-5Q-5L) at 1 year. 
6.5 Surgical 
Technique 
(rationale 1) 
Surgeons selected to participate 
in this study will be familiar with 
the NOVOSTITCH PRO product, 
or will receive training per 
standard SN procedures if not 
familiar. 
Surgeons selected to participate in 
this study will be familiar with the 
NOVOSTITCH PRO product, or will 
receive training prior to enrolling any 
subjects per standard SN procedures 
if not familiar. 
7.3 Exclusion 
Criteria (rationale 1) 
Previously enrolled in the study 
(no bilateral subjects); 
Previously enrolled in the study (no 
bilateral knee surgeries); 
7.4 Screening 
(rationale 1) 
Of these 90 subjects, 45 subjects 
will have horizontal cleavage 
meniscal tears and 45 will have 
complex meniscal tears. Subjects 
will be enrolled as they meet 
eligibility and consent to the study. 
Therefore, once a group has met 
the 45 subjects, screening will 
stop within that group, and 
screening and enrollment will 
continue only in the other group 
until all 90 subjects are enrolled. 
Of the 90 subjects, at least 40 
subjects will have horizontal cleavage 
meniscal tears and at least 40 will 
have complex meniscal tears. 
Subjects will be enrolled as they meet 
eligibility and consent to the study. 
Therefore, if a group enrolls 50 
subjects, screening will stop within 
that group, and screening and 
enrollment will continue only in the 
other group until all 90 subjects are 
enrolled. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 81 of 94 
 
7.5 Informed 
Consent (rationale 
1) 
Consent cannot be coerced and 
can be completed at any time 
prior to the meniscus surgery. 
If the subject does not speak 
English, an in-person  or 
telephone interpreter will be used 
and the entire consent form will be 
translated for the subject. The 
subject will be able to ask any 
questions that will be answered by 
study personnel through the use 
of an interpreter. If an interpreter 
is used, the subject will sign a 
short consent form, along with a 
witness, and documentation of the 
translator will be included on the 
form. A copy of the signed short 
informed consent document and a 
copy of the English consent form 
will be provided to the subject, 
and copies will be placed in the 
subject’s record or chart as 
required by the site, with the 
original filed in the Investigator 
Site File (ISF). 
Consent cannot be coerced and must 
be completed at any time prior to the 
first study activity. 
If the subject does not speak English, 
the individual will be given a consent 
form in their native language, or a 
bilingual study member or an in- 
person or telephone interpreter will be 
used and the entire consent form will 
be translated for the subject. The 
subject will be able to ask any 
questions that will be answered by 
study personnel, and as required 
through the use of the interpreter. If 
an interpreter is used, the subject will 
sign a short consent form, along with 
a witness, and documentation of the 
translator will be included on the 
form. A copy of the signed consent 
form, or short informed consent 
document and a copy of the English 
consent form as applicable, will be 
provided to the subject, and copies 
will be placed in the subject’s record 
or chart as required by the site, with 
the original filed in the Investigator 
Site File (ISF). 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 82 of 94 
 
7.8.1 Withdrawal 
from Study (rational 
1) 
Concurrent illness 
Concurrent debilitating illness 
7.8.3 Use of Data 
Following 
Withdrawal 
(rationale 1) 
In cases where the subject 
withdraws consent, or the subject 
is withdrawn from the study by the 
PI, data collected up to the point 
of withdrawal may be used, but no 
additional data for that subject 
may be collected except for 
subjects who have consented and 
have an adverse event that is 
being followed to resolution or 
receive a revision surgery of the 
study knee as detailed in section 
7.8.1 above (until the end of the 
study). 
In cases where the subject withdraws 
consent, or the subject is withdrawn 
from the study by the PI, data 
collected up to the point of withdrawal 
may be used, but no additional data 
for that subject may be collected 
except for subjects who have 
consented and have an adverse 
event that is being followed to 
resolution or receive a revision 
surgery of the study knee as detailed 
in section 7.8.1 above. 
8.1 Study Design 
(rationale 1) 
However, primary outcome 
measures that will be examined 
include whether the re-operation 
survival rate will be similar or less 
than historical rates (78-91%)10,27 
However, primary outcome measures 
that will be examined include whether 
the reoperation survival rate at 12 
months will be similar or less than 
historical rates (78-91%)10,27 
Figure 8.1-1 Study 
Flowchart 
(rationales 3 and 7) 
Original image 
Updated image removing the PROs 
from the 3-month visit, separating the 
EQ-5D-5L from the Patient 
Satisfaction CRF, and removing the 
Patient Satisfaction CRF at baseline 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 83 of 94 
 
Table 9.1-1 Study 
Procedures by Visit 
(rationales 3 and 7) 
Original table 
Updated table by correcting the 
typographical error in which the 
explanation was written as 5 instead 
of 4, removing the PROs from the 3- 
month visit, separating the EQ-5D-5L 
from the Patient Satisfaction CRF, 
and removing of the Patient 
Satisfaction CRF at baseline 
9.1.2 Visit 1 
(rationale 1) 
Screen Failure subjects should 
not be assigned a Subject ID 
number, but their demographic 
information must be captured in 
the appropriate CRF and/or log 
with the reason for screen failure 
specified. 
Screen Failure subjects who are 
consented but do not complete the 
baseline screening will be assigned a 
Subject ID number, and their 
demographic information captured in 
the appropriate CRF and/or log with 
the reason for screen failure 
specified. 
9.1.1 Summary 
(rationale 8) 
Previously in Section 9.1.8 
Subjects may complete the patient 
CRFs (PROs (KOOS, IKDC 
Subjective, and Lysholm), Post- 
Operative Plan/Return to Work, 
Patient Satisfaction, and EQ-5D-5L) 
either on paper, or on a secure 
electronic device such as a computer, 
mobile phone, or tablet. 
Subjects who are unable to return to 
the site for follow-up visits may 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 84 of 94 
 
complete the PROs (KOOS, IKDC 
Subjective, and Lysholm), Post- 
Operative Plan/Return to Work, 
Patient Satisfaction, and EQ-5D-5L 
CRFs on paper and return by mail, 
electronically by email, or online 
through a secure link provided by the 
site. The follow-up general 
health/concomitant medications and 
concomitant therapies CRF and 
safety assessment may be conducted 
over the telephone with study staff. 
As required, documents will be 
translated into the appropriate 
language for the individual, and an 
interpreter will be used over the 
telephone. 
Subjects may be provided participant 
stipends as agreed upon by Sponsor 
and the site, and as allowed by the 
site’s standard operating 
procedures/regulations and the IRB. 
Stipends amounts may cover costs 
associated with the study participant 
to complete follow-up visits, but 
cannot be coercive. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 85 of 94 
 
9.3 Health 
Economics 
(rationales 1 and 7) 
1. Employment status pre- 
surgery: Currently 
working/employed (Yes/No). 
1. Employment status pre-surgery: 
Currently working/employed 
category) and job type. 
2. Nature of work: 
Laborer/Sedentary work 
(Sedentary deined as “involves 
occasional lifting of no more than 
ten pounds and sitting with 
occasional walking and 
standing”). 
2. Nature of work: Laborer/Sedentary 
work (Sedentary deined as “involves 
occasional lifting of no more than ten 
pounds and sitting with occasional 
walking and standing”). 
3. Return to work after surgery (Days) 
and type of work. 
3. Return to work after surgery 
(Days). 
4. Patient Satisfaction at 1 year and 2 
years. 
4. Patient Satisfaction at baseline, 
1 year, and 2 years. 
10.4.3 Analysis of 
Other Endpoint(s) 
(rationale 1) 
The number and proportion of 
subjects experiencing freedom 
from re-operation where 
NOVOCUT Suture Manager has 
been used alongside the 
NOVOSTITCH PRO will be 
presented at 6 months, 1 year 
and 2 years together with a 95% 
confidence interval (calculated 
using the Clopper-Pearson Exact 
method)36. 
The number and proportion of 
subjects experiencing device 
deficiencies where NOVOCUT Suture 
Manager has been used alongside 
the NOVOSTITCH PRO with a 95% 
confidence interval (calculated using 
the Clopper-Pearson Exact 
method)36. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 86 of 94 
 
21.2 
INSTRUCTIONS FOR USE 
 
Refer to the Instruction for Use supplied with this protocol. 
 
21.3 
EQUIPMENT AND SPECIAL INSTRUCTIONS 
 
Not applicable. 
 
21.4 
ADDITIONAL INFORMATION 
 
Not applicable. 
 
21.5 
PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155:2011) 
 
1. General: 
a. 
The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of 
the subjects involved in the clinical investigation. 
2. Qualification of the PI. The PI shall: 
a. 
Be qualified by education, training, and experience to assume responsibility for the 
proper conduct of the clinical investigation in accordance with this International 
Standard; evidence of such qualifications of the PI and key members of the 
investigation site team shall be provided to the Sponsor through up-to-date Curriculum 
Vitae (CV) or other relevant documentation, 
b. 
Be experienced in the field of application and trained in the use of the investigational 
device under consideration, 
c. 
Disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation or interpretation of results, and 
d. 
Be knowledgeable with the method of obtaining informed consent. 
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 87 of 94 
 
a. 
Has the required number of eligible subjects needed within the agreed recruitment 
period, and 
b. 
Has one or more qualified investigators, a qualified investigation site team and 
adequate facilities for the foreseen duration of the clinical investigation. 
4. Communication with the IEC. The PI shall: 
a. 
Provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC. 
b. 
Comply with the requirements described in 4.5 of ISO 14155:2011: 
i. 
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 
consent form and any other written information provided to subjects; procedures 
for recruiting subjects and advertising materials, if any; a copy of the CV of the 
PI(s) for with the IEC has oversight. 
ii. 
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, 
prior to commencing the clinical investigation. 
iii. 
Submit the following to the IEC if required by national regulations, the protocol or 
IEC, whichever is more stringent: 
1. 
SAEs 
2. 
Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 
deviations made to protect the rights, safety, and well-being of human 
subjects under emergency circumstances. 
3. 
Progress reports, including safety summary and deviations. 
4. 
Amendments to any documents already approved by the IEC. 
5. 
If applicable, notifications of suspension or premature termination. 
6. 
If applicable, justification and request for resuming the clinical investigation 
after suspension. 
7. 
Clinical investigation report or summary. 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 88 of 94 
 
iv. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation: 
1. 
Approval/favorable opinion of amendments, 
2. 
Approval of the request for deviations that can affect the subject’s rights, 
safety, and well-being or scientific integrity of the clinical investigation, 
3. 
Approval for resumption of a suspended clinical investigation if applicable. 
c. 
Obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, 
if required. 
d. 
Promptly report any deviations from the protocol that affect the rights, safety or well- 
being of the subject or the scientific integrity of the clinical investigation, including those 
which occur under emergency circumstances, if required by the IEC, protocol or 
national regulations. In particular circumstances, the communication with the IEC can 
be performed by the Sponsor, partly or in full, in which case the Sponsor shall keep the 
Principal Investigator informed. 
5. Informed consent process. The PI shall: 
a. 
General: 
i. 
Informed consent shall be obtained in writing from the subject and the process 
shall be documented before any procedure specific to the clinical investigation is 
applied to the subject; except when special circumstances for emergency 
treatments apply (see below). 
b. 
Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
requirements also apply with respect to informed consent obtained from a subject’s 
legally authorized representative: 
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent 
process, 
ii. 
Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation, 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 89 of 94 
 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate, 
iv. 
Not waive or appear to waive the subject’s legal rights, 
v. 
Use native non-technical language that is understandable to the subject, 
vi. 
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation, 
vii. 
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process, 
viii. 
Show how informed consent will be obtained in special circumstances (see below) 
where the subject is unable to provide him or herself, and , 
ix. 
Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation. 
c. 
Special circumstances for informed consent (the following provisions are subject to 
national regulations): 
i. 
Subject needing legally authorized representatives: informed consent may be 
given by the legally authorized representative only if a subject is unable to make 
the decision to participate in a clinical investigation (e.g., infant, child, or juvenile, 
seriously ill or unconscious subject, mentally ill person, mentally handicapped 
person). In such cases, the subject shall also be informed about the clinical 
investigation within his/her ability to understand. 
ii. 
Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the process. 
The written informed consent form and any other information shall be read aloud 
and explained to the prospective subject or his/her legally authorized 
representative and, whenever possible, either shall sign and personally date the 
informed consent form. The witness also signs and personally dates the informed 
consent for attesting that the information was accurately explained and that the 
informed consent was freely given. 
iii. 
Emergency treatments: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 90 of 94 
 
1. 
For clinical investigations involving emergency treatments, when prior 
informed consent of the subject is not possible because of the subject’s 
medical condition, the informed consent of the subject’s legally authorized 
representative, if present, shall be requested. 
2. 
When it is not possible to obtain prior informed consent from the subject, and 
the subject’s legally authorized representative, is not available, the subject 
may still be enrolled if a specific process has been described in the protocol. 
3. 
Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the 
clinical investigation and about all aspects of the clinical investigation. 
4. 
The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows. 
d. 
The Principal Investigator may not enroll a subject without obtaining informed consent 
of the subject or his/her legally authorized representative only when the following 
conditions are fulfilled: the prospective subject fulfils the emergency conditions and is 
obviously in a life-threatening situation; no sufficient clinical benefits are anticipated 
from the currently available treatment; there is a fair possibility that the life-threatening 
risk to the prospective subject can be avoided if the investigational device is used; 
anticipated risks are outweighed by the potential benefits of applying the investigational 
device ; the legally authorized representative cannot be promptly reached and informed. 
e. 
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
language that is understandable to the subject (or the subject’s legally authorized 
representative): 
i. 
Description and purpose, 
ii. 
Potential benefits, 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, 
fetus or nursing infant, 
iv. 
Alternative procedures, 
v. 
Confidentiality, 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 91 of 94 
 
vi. 
Compensation, 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation, 
viii. 
Information on the role of Sponsor’s representative in the clinical investigation, 
ix. 
Contact persons, 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available to 
the subject, 
xi. 
Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical investigation, 
xii. 
Termination procedures. 
f. 
Informed consent signature shall contain the following: 
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
investigator’s instructions, 
ii. 
A statement declaring that refusal of participation incurs no penalty for the 
subject, 
iii. 
A statement declaring that discontinuation at any time incurs no penalty for the 
subject, 
iv. 
A statement with regard to the possible consequences of withdrawal, 
v. 
An acknowledgment of the information provided and confirmation that all the 
subject’s questions were answered, 
vi. 
A statement confirming that the subject or his/her legally authorized 
representative agrees to the use of the subject’s relevant personal data for the 
purpose of the clinical investigation, 
vii. 
A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor’s representatives, regulatory authorities and 
IEC representatives will be granted direct access to the subject’s medical records. 
g. 
New information: if new information becomes available that can significantly affect a 
subject’s future health and medical care, that information shall be provided to the 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 92 of 94 
 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing. 
h. 
Ensure compliance with the applicable regulatory requirements and ethical principles 
for the process of obtaining informed consent, and 
i. 
Ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a. 
Indicate his/her acceptance of the protocol in writing, 
b. 
Conduct the clinical investigation in compliance with the protocol, 
c. 
Create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits, 
d. 
Ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use, 
e. 
Propose to the Sponsor any appropriate modification(s) of the protocol or 
investigational device or of the use of the investigational device, 
f. 
Refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. 
Document and explain any deviation from the approved protocol that occurred during 
the course of the clinical investigation, 
h. 
Ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation, 
i. 
Ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable, 
j. 
Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k. 
Maintain the device accountability records, 
l. 
Allow and support the Sponsor to perform monitoring and auditing activities, 
m. Be accessible to the monitor and respond to questions during monitoring visits, 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 93 of 94 
 
n. 
Allow and support regulatory authorities and the IEC when performing auditing 
activities, 
o. 
Ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and 
p. 
Review and sign the clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall: 
a. 
Provide adequate medical care to a subject during and after a subject's participation in 
a clinical investigation in the case of adverse events, 
b. 
Inform the subject of the nature and possible cause of any adverse events experienced, 
c. 
Provide the subject with the necessary instructions on proper use, handling, storage, 
and return of the investigational device, when it is used or operated by the subject, 
d. 
Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required, 
e. 
Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical investigation, and make the necessary arrangements for 
emergency treatment, including decoding procedures for blinded/masked clinical 
investigations, as needed, 
f. 
Ensure that clinical records are clearly marked to indicate that the subject is enrolled in 
a particular clinical investigation, 
g. 
If appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided), 
h. 
Inform, with the subject's approval or when required by national regulations, the 
subject's personal physician about the subject's participation in the clinical investigation, 
and 
i. 
Make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's rights. 
8. Safety reporting. The Principal Investigator shall: 

CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith + Nephew PLC and Smith + Nephew, Inc. and is 
intended for use only by Smith + Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith + Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith + Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision A; SOP-CD-05 Clinical Protocols 
 
 
Study Protocol—Device 
Circumferential Compression STITCH Repairs of Complex 
and Horizontal Cleavage Meniscal Tears 
Number: 
NOVOSTITCH.2019.09 
Version: 2.0, 07/APR/2020 
Page: Page 94 of 94 
 
a. 
Record every adverse event and observed device deficiency, together with an 
assessment, 
b. 
Report to the Sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect; this information shall 
be promptly followed by detailed written reports, as specified in the protocol, 
c. 
Report to the IEC serious adverse events and device deficiencies that could have led to 
a serious adverse device effect, if required by the national regulations or protocol or by 
the IEC, 
d. 
Report to regulatory authorities serious adverse events and device deficiencies that 
could have led to a serious adverse device effect, as required by the national 
regulations, and 
e. 
Supply the Sponsor, upon Sponsor's request, with any additional information related to 
the safety reporting of a particular event.