A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)
Phase: NA
Conditions: Meniscal Tear, Meniscus Tear
Sponsor: Smith & Nephew, Inc.

Proprietary and Confidential 
 
 
 
 
A Prospective, Non-randomized, Multi-Center Investigation of All-
suture-based Repair of Horizontal Meniscal Tears (STITCH Study) 
 
 
 
 
SPONSOR: 
Ceterix Orthopaedics, Inc. 
959 Hamilton Avenue 
Menlo Park, CA 94025 
(650) 316-8660 
 
 
 
 
 
PROTOCOL NUMBER: 
 
 
 
 
 
CTX-CP001 
VERSION:  
Version C 
DATE:  
December 16, 2014 
 
 
 
 
 
 
 

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Table of Contents 
1. ABBREVIATIONS, ACRONYMS AND DEFINITIONS.................................................. 1 
2. PROTOCOL SYNOPSIS ...................................................................................................... 2 
3. INTRODUCTION, BACKGROUND AND RATIONALE ................................................ 5 
3.1. 
Background ............................................................................................................................... 5 
3.2. 
Rationale and Justification for the Study ....................................................................... 6 
a. 
Rationale for the Study Objectives ............................................................................................ 6 
b. 
Rationale for Study Population .................................................................................................. 6 
c. 
Rationale for Study Design ............................................................................................................ 7 
4. STUDY DESIGN ................................................................................................................... 7 
4.1. 
Hypotheses ................................................................................................................................ 7 
4.2 
General Design .......................................................................................................................... 7 
4.3. 
Objectives .................................................................................................................................. 7 
4.4. 
Potential Risks and Benefits ............................................................................................... 7 
a. 
Risks of Study Participation ......................................................................................................... 7 
b. 
Potential Benefits of Participation ........................................................................................... 8 
4.5. 
Study Assessments ................................................................................................................. 8 
a. 
Outcome Assessments ..................................................................................................................... 8 
b. 
Safety Variable (see Section 7.1 for definitions) ............................................................... 9 
c. 
Patient and Procedural Variables ............................................................................................. 9 
5. STUDY POPULATION ........................................................................................................ 9 
5.1. 
Planned Number of Subjects ............................................................................................... 9 
5.2. 
Criteria for Recruitment ...................................................................................................... 9 
a. 
Diagnosis and Main Criteria for Enrollment ....................................................................... 9 
b. 
Inclusion Criteria ............................................................................................................................... 9 
c. 
Exclusion Criteria ............................................................................................................................ 10 
5.3. 
Withdrawal Criteria ............................................................................................................ 11 
6. METHODS AND PROCEDURES .................................................................................... 11 
6.1. 
Method for Assigning Subjects ........................................................................................ 11 
6.2. 
Study Visits and Procedures ............................................................................................ 12 
a. 
Screening Visit (Study Visit 1); within 4 weeks of the procedure ........................ 12 
b. 
Surgery and Rehabilitation (Study Visit 2) ....................................................................... 12 
c. 
First Follow-up [7-15 days] (Study Visit 3) ....................................................................... 13 
d. 
Second Follow-up [90 Day ± 7 days] (Study Visit 4) .................................................... 13 
e. 
Third Follow-up [185 Day ± 14 days] (Study Visit 4) .................................................. 13 
f. 
Fourth Follow-up [365 Day ± 30 days] (Study Visit 5) ................................................. 14 
g. 
Fifth Follow-up [730 Day ± 30 days] (Study Visit 6) .................................................... 14 
7. SAFETY MEASUREMENTS ............................................................................................ 14 
7.1. 
Definitions .............................................................................................................................. 14 
7.2. 
Collecting, Recording and Reporting of Complications ......................................... 15 
7.3. 
Study Monitoring Plan, Auditing, and Inspecting .................................................... 16 
a. 
Study Monitoring Plan .................................................................................................................. 16 

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b. 
Medical Monitoring ........................................................................................................................ 16 
c. 
Auditing and Inspecting ............................................................................................................... 16 
8. DATA HANDLING AND RECORD KEEPING ............................................................. 17 
8.1. 
Data Quality Assurance ..................................................................................................... 17 
8.2. 
Confidentiality ...................................................................................................................... 17 
8.3. 
Source Documents ............................................................................................................... 18 
8.4. 
Case Report Forms (see Appendix 6) ........................................................................... 18 
8.5. 
Retention of Trial Documents and Records ............................................................... 18 
9. STATISTICAL PLAN ........................................................................................................ 18 
9.1. 
Subject Population(s) for Analysis ................................................................................ 18 
9.2. 
Statistical Methods .............................................................................................................. 18 
10. ETHICAL CONSIDERATIONS ..................................................................................... 19 
10.1. 
IRB Review ........................................................................................................................... 19 
10.2. 
Informed Consent ............................................................................................................. 19 
11. CONFLICT OF INTEREST ............................................................................................ 19 
12. PUBLICATION PLAN .................................................................................................... 20 
13. BIBLIOGRAPHY ............................................................................................................ 20 
14. STUDY ACTIVITY SCHEDULE ................................................................................... 24 
15. LIST OF ATTACHMENTS ............................................................................................ 25 
 
 
 
 

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STUDY PROTOCOL 
 
1. 
ABBREVIATIONS, ACRONYMS AND DEFINITIONS 
 
All Suture-Based Technique:  A repair technique (all-inside, inside-out, outside-in 
or combination thereof) utilizing only suture without implanting any other material 
intended to anchor and/or replace suture material. 
BMI:  Body Mass Index 
Complex Tear:  Multiple discreet tears, tears with multiple planes, or meniscal 
tissue incapable of holding suture.   
Consented Patient:  A patient who, after the screening process, grants consent to 
participate in the trial. 
CFR:  Code of Federal Regulations 
CRF: Case Report Form; includes all study forms. 
Enrolled Subject:  A patient who has been consented, meets all criteria for 
inclusion immediately prior to treatment and receives all suture-based repair of 
meniscal tear. 
HT:  Horizontal tear (of the meniscus); the majority of the tear is oriented primarily 
(but not exclusively) parallel to the plane of knee joint dividing the structure into 
superior and inferior flaps.  For the purpose of this protocol, HT includes obliquely-
oriented tears. These tears may open at the central apex or along the inferior 
surface of the meniscus.  Some horizontal tears may have a radial component (bird 
beak) in the central White Zone. 
HIPAA:  Health Insurance Portability and Accountability Act 
IKDC:  International Knee Documentation Committee 
IRB:  Institutional Review Board 
ISAKOS:  International Society of Arthroscopy, Knee Surgery and Orthopaedic 
Sports Medicine 
KOOS:  Knee injury and Osteoarthritis Outcome Score 
PCL: Posterior Cruciate Ligament 
Protocol Deviation:  A protocol deviation is any change, divergence, or departure 
from the study design or procedures of a research protocol that is under the 
Investigator’s control and that has not been approved by the IRB. 
Protocol Violation:  A protocol violation is a deviation from the IRB-approved 
protocol that may affect the subject's rights, safety, or well-being and/or the 
completeness, accuracy and reliability of the study data. 
Red Zone:  The well-vascularized peripheral-most ~30% of the meniscus. 
Red-White Zone: The transition between the outermost and innermost portions of 
the meniscus where vascularity diminishes from peripheral to central. 
Subject: A consented patient who has been enrolled in the study. 
White Zone: The inner (avascular) one-third of the meniscus. 
 
 
 

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2. 
PROTOCOL SYNOPSIS 
 
Study Title 
A Prospective, Non-randomized, Multi-center 
Investigation of All Suture-based Repair of Horizontal 
Meniscal Tears 
Protocol Number 
CTX-CP001 
Study Objectives 
The primary objectives of this study are to document 
horizontal meniscus tear repair, characterize the 
reoperation survival curve and assess improvements in 
knee pain and function. 
Study Design 
Interventional, non-randomized, single-arm assignment, 
open label clinical trial of suture-based meniscal repair. 
Endpoints 
Freedom from reoperation of the index meniscus repair 
site at 6 months, 1 year, and 2 years; 
Improvements in knee pain and function as measured by 
KOOS, IKDC Knee evaluation, Lysholm Knee scale and 
Tegner Activity Scale 
Subject Population 
The study population will include 30 otherwise healthy 
subjects 18 to 60 years of age (inclusive), enrolled at up to 
10 investigational sites in the United States, who have a 
horizontal meniscus tear. 
Analysis Populations 
Data obtained from all enrolled subjects will be analyzed 
on a per-treatment (PT) basis, which will include all 
enrolled subjects who receive the protocol-defined 
treatment of suture-based meniscal repair. 
Study Duration 
Subjects will be followed for a total of 2 years. 
Screening Inclusion 
Criteria 
Subjects of either gender may be eligible for inclusion in 
the study only if they meet all of the following criteria at 
screening:  
 Able and willing to give informed consent by 
voluntarily providing written informed consent in 
accordance with governing Institutional Review 
Board 
 18 to 60 years of age, inclusive at the time of 
screening; 
 History indicative of meniscal pathology (e.g., pain, 
mechanical symptoms described as locking, 
clicking or giving way); 
 Physical exam consistent with meniscus tear (e.g., 
locked joint, joint line tenderness and/or pain on 
meniscal compression); 

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 If prior ligament reconstruction, the study knee is 
clinically stable; 
 Preoperative MRI evidence consistent with a 
horizontal/oblique meniscus tear in the 
symptomatic compartment; 
 Healthy and not pregnant 
Screening Exclusion 
Criteria 
Subjects will be excluded from the study for any of the 
following reasons during screening:  
 Arthritis in the study knee (Kellgren-Lawrence 
Grade 3 or higher); 
 Body Mass Index (BMI) ≥35 kg/m2; 
 Previous meniscal repair or meniscectomy of the 
study meniscus; 
 Unstable knee; 
 Malalignment of the study knee >5 degrees and/or 
requiring osteotomy and/or correction; 
 History of constitutional/systemic 
inflammatory/arthritic problem or pain condition, 
history of knee infection, vascular condition of legs, 
benign neoplasms of knee, hepatitis, HIV, 
drug/alcohol abuse, tobacco abuse, cancer; 
 Expected to undergo any other primary treatment 
of the knee; 
 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. 
 Pregnant or planning to become pregnant in the 
next 2 years. 
Arthroscopy 
Inclusion Criteria 
Consented subjects may be included in the study only if, 
upon arthroscopic inspection, their meniscal study lesion 
meets all of the following criteria established by the 
International Society of Arthroscopy, Knee Surgery and 
Orthopaedic Sports Medicine (ISAKOS): 
 Zone location: circumferential location of tear 
includes locations within 10mm of the peripheral 
rim of the meniscus; 
 Radial location: any location from anterior to 
posterior; 
 Tear pattern: primarily horizontal or oblique in 
orientation (not to exceed 45 degrees from 
horizontal); 

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 Compartment: either lateral or medial, but not 
both; 
 Opposite compartment meniscal tear (if present) 
limited to the central portion (i.e., Zone 3/“white 
zone”); 
 Tear amenable to repair with all suture-based 
techniques. 
Arthroscopy 
Exclusion Criteria 
Subjects will be excluded from the study if their study 
meniscus lesion meets any of the following criteria at 
arthroscopy: 
 Tear pattern: primarily vertical longitudinal or 
radial in orientation; 
 Partial meniscectomy of any portion of the study 
meniscus extends beyond the central portion (i.e., 
Zone 3/“white zone”); 
 Intact or partially intact meniscus tear that, in the 
opinion of the Investigator, does not require repair; 
 Poor meniscal tissue quality such that it will not 
hold a suture; 
 Any portion of the meniscus repair that, in the 
opinion of the Investigator, is best treated using an 
implant other than suture; 
 Clinically significant (zone 1 and/or zone 2) tear in 
the contralateral compartment to the study 
meniscus; 
 Performance of a significant concomitant 
procedure intended as a therapeutic intervention 
on the study knee; 
 Arthritis in the surgical knee Modified Outerbridge 
Grade III or higher. 
Study Visits 
Screening (Study Visit 1): Informed consent, screening 
eligibility criteria, demographics, patient reported 
outcomes, MRI (within 6 months) and X-rays (within 6 
months); 
Procedure (Study Visit 2): Arthroscopy eligibility criteria, 
enrollment, meniscal-repair, images, complications; 
details of pathology and procedure 
1st postop [Day 7-15] (Study Visit 3): Complications; 
2nd postop [Day 90±7 days] (Study Visit 4): Complications, 
patient reported outcomes; 
3rd postop [Day 185±14 days] (Study Visit 5): 
Complications, patient reported outcomes, visual 
examination of meniscus tear (when available); 

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4th postop [Day 365±30 days] (Study Visit 6): 
Complications, patient reported outcomes, MRI; 
5th postop [Day 730±30 days] (Study Visit 7): 
Complications, patient reported outcomes, X-Rays; 
Rehabilitation Plan 
All subjects will follow their Investigator’s preferred 
rehabilitation plan. At a minimum, all subjects must meet 
the following post-operative thresholds: 
 Weight bearing as tolerated 
 Hinged knee brace locked in extension when 
walking (4-6 weeks), released to 90 degrees for 
sitting/driving 
 No squatting or stand up/sit down motions until 
after 6 weeks post-op 
 No cutting or pivot sports until after 6 months 
post-op 
Sponsor 
Ceterix Orthopaedics 
959 Hamilton Avenue 
Menlo Park, CA  94025 
(650) 316-8660 
 
3. 
INTRODUCTION, BACKGROUND AND RATIONALE 
This document is a protocol for a human research study.  This study is to be 
conducted in accordance with United States government research regulations, 
applicable international standards of Good Clinical Practice and institutional 
research policies and procedures.   
 
3.1. 
Background 
Meniscal pathology, primarily in the form of a tear, is very common and frequently 
symptomatic.  In the United States alone, over 500,000 meniscectomies were 
performed in 2006.1  Historically, treatment for meniscal tears consisted of open 
total meniscectomy.  As surgeons began evaluating the long-term impact of total 
meniscectomy and, in parallel, as biomechanical studies began demonstrating the 
vital importance of the meniscus on knee function,2,3,4,5,6,7,8,9   it became apparent 
meniscectomy had consequential and deleterious effects on the knee over 
time.10.,11,12,13  An interest in improving the treatment of meniscal pathology 
emerged in the orthopedic community. 
 
As the understanding of the importance of the meniscus evolved, so too did 
technologies enabling surgeons to perform more specific and limited procedures on 
torn menisci with arthroscopic approaches.14   As a result, many patients have 
undergone arthroscopic-assisted meniscus-preserving surgery (limited removal, 
repair or a combination of the two procedures) over the past 30 years. Compared to 
outcomes when total meniscectomy was standard of care, clinical outcomes for 
patients with meniscal tears today have improved substantially.15 Although less 

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anatomical destruction is the preferred strategy, when a tear is deemed not 
amenable to repair, partial meniscectomy is the next line of treatment. 
 
Although repair when feasible is the current standard of care for meniscal 
tears,16,17,18,19,20,21,22,23,24 it is most often performed on primarily, vertically-oriented 
tears for several reasons.  Firstly, the anatomic constraints of the knee limit 
arthroscopic placement of sutures and non-suture devices in such a way that a 
perpendicular approach to the tear is the least technically challenging.  Vertical 
tears present in a substantially perpendicular plane relative to the arthroscopic 
access ports.   Secondly, the literature is replete with data demonstrating a high 
efficacy rates in these tears.25,26,27,28,29,30,31   
 
Reparability and healing potential are not identical; however the concepts are often 
used interchangeably.  One term is correctly applied to the technical feasibility of 
performing a repair and maintaining the repair integrity over time; the other is a 
biologic phenomenon.  The current teaching regarding horizontal/oblique and tears 
is that they are most often irreparable.32,33,34,35,36  As such, little clinical 
documentation regarding the feasibility of repairing these tears exists.  
Furthermore, contrary to clinical doctrine, the scant existing literature on the 
subject challenges the understanding of the healing potential of horizontal/oblique 
tears by suggesting that repair has successful outcomes anywhere from 50-100% of 
the time. 37,38,39,40,41,42,43,44    Clearly additional prospective assessments of 
horizontal/oblique tears is needed. 
 
Horizontal tears are notable for a few reasons:  1) they are common, comprising up 
to 20% of meniscus tears 45,46,47; 2) despite improvements in meniscal repair 
methods, the techniques have been difficult to employ successfully across these 
particular tears. With newer suture delivery methods enabling surgeons to more 
easily place sutures in patterns that reduce these tears, it is possible to further 
assess and document their reparability.  This study will begin that process by 
examining and documenting the ability to successfully repair horizontal meniscus 
tears using all suture based techniques. 
 
3.2. 
Rationale and Justification for the Study 
 
a. 
Rationale for the Study Objectives 
Although the clinical consensus holds that horizontal tears are often irreparable, 
there are no prospective, multi-center trials in the literature that document 
successful repair of the meniscus, surgical reoperation rates for meniscal tears and 
improvements in knee pain and function. 
 
 
b. 
Rationale for Study Population 
The study is limited to healthy subjects with horizontal meniscal tears.  Although 
these injuries can occur in any age group, slightly younger age range (18-60 years of 
age) allows inclusion of knees with less likelihood of significant arthritic changes 

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which may mask measurement of knee pain and function improvements following 
the treatment procedure. 
 
c. 
Rationale for Study Design 
It is well established in the literature that meniscectomy leads to increased risk of 
late osteoarthritis, and conversely, that repairing the meniscus reduces this risk.  
The clinical consensus is that preservation of meniscal tissue should be the goal 
whenever possible.  The alternative for these patients is meniscectomy (a failure 
endpoint in this study), therefore there is no available control.  A prospective, non-
randomized, single-arm assignment study design is the best method for obtaining 
objective data for clinicians and patients in weighing the viability of meniscal repair 
versus primary meniscectomy. 
 
4. 
STUDY DESIGN 
 
4.1. 
Hypotheses 
No formal hypotheses testing will be done.  However, primary outcome measures 
that will be examined include:  A substantial proportion of the subjects will show 
meniscus healing at 6 months.  The two-year reoperation survival rate will be 
similar or less than historical rates.  Patient reported outcomes will be improved at 
six-months following the procedure. 
 
4.2 
General Design 
The study is an interventional trial designed as a non-randomized, single-arm, open-
label study of repairs of horizontal of the meniscus using commercially available 
products.  The study will enroll 30 subjects at up to 10 investigational sites in the 
United States.  
 
4.3. 
Objectives 
The primary objectives of this study are to assess reoperation rate, improvements in 
knee pain and function, and meniscus repair rate following all-suture-based repair 
of the horizontal meniscal tear.   
 
4.4. 
Potential Risks and Benefits 
 
a. 
Risks of Study Participation 
 
A subject has the risk of suture reaction, a risk that exists with any surgical 
procedure utilizing suture material.  Additionally, although some studies suggest 
that repairing horizontal tears can be effective, this may not be the case in this 
study.  Some or all subjects in the study may fail to gain relief of their symptoms or 
have a recurrence of their symptoms, necessitating subsequent surgical procedures 
to solve their pain and mechanical symptoms. 
 

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In-office needle arthroscopy (e.g. VisionScope) diagnostic testing risk is minimal. 
The probability and magnitude of harm or discomfort anticipated in this research 
study is no greater than that ordinarily encountered during the performance of 
routine diagnostic tests. The diagnostic device used in this study is approved for 
diagnostic procedures by the FDA and therefore this study does not present new 
risks to patients and should be considered a non-significant risk study based upon 
the definitions in 21 CFR 812.3. The most common risk associated with an in-office 
needle arthroscopy procedure is slight pressure or discomfort from needle/device 
insertion.  Least common risks are minor bleeding in and around the joint area.  And 
while rare, there is always a risk of infection in the joint due to the introduction of a 
foreign object in the body. Device-related potential complications are minimal. The 
currently available device (VisionScope) has already passed rigorous electrical 
safety, electromagnetic compatibility, biocompatibility and sterility testing from its 
FDA 510(k) submission process, as documented per the VisionScope Quality System 
Manual and filed in the FDA 510(k) summary: 
http://www.accessdata.fda.gov/cdrh_docs/pdf10/K101734.pdf. 
At a bare minimum, currently employed standards of care for in-office 
arthrocentesis techniques will be used for in office arthroscopy procedures. This 
includes sterile preparation with betadine and alcohol, and sterile draping.   
  
Patient follow-up will be governed by the treating physician’s traditional post-
operative regime for knee arthroscopies and repairs.  
 
b. 
Potential Benefits of Participation  
A large body of evidence exists to support the concept that successful meniscus 
repair facilitates long-term joint preservation.  In spite of this, it is uncommon for 
horizontal meniscus tears to be repaired.  Participation in this study provides a 
subject the opportunity to receive a repair of the torn meniscus, which is not widely 
performed within the medical community.  The patient will also gain the benefits of 
an anatomy preserving procedure and to contribute to a growing body of evidence 
regarding joint preservation.  If the procedure is effective, subjects may obviate or 
substantially delay the need for additional reconstructive procedures on their knees 
in the future. 
 
4.5. 
Study Assessments 
For timing of study assessments activities and visit windows see Section 14. 
 
a. 
Outcome Assessments  
 International Knee Documentation Committee Subjective Knee Evaluation 
Form (IKDC Knee Evaluation) 
 Knee Injury and Osteoarthritis Outcome Score (KOOS) 
 Lysholm Knee Questionnaire 
 Tenger Activity Scale 
 In-office needle arthroscopy assessment of meniscus repair (when 
performed) 

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 Freedom from reoperation on the index meniscus repair site; 
 Condition of meniscal tissue per MRI (Appendix 7); 
 Joint condition per X-ray (Appendix 7). 
 
b. 
Safety Variable (see Section 7.1 for definitions) 
 Safety follow-up 
 
c. 
Patient and Procedural Variables 
 Patient demographics and knee pathology history 
 Details of procedure 
 Details of tear 
 
5. 
STUDY POPULATION 
 
5.1. 
Planned Number of Subjects 
A total of 30 subjects will be enrolled.  
 
5.2. 
Criteria for Recruitment 
 
a. 
Diagnosis and Main Criteria for Enrollment 
Subjects will be recruited for the study through the clinical practices of the 
Investigators.  The study population includes otherwise healthy subjects with a 
symptomatic meniscus tear, who are able and willing to participate and who qualify 
for study inclusion based on specific eligibility criteria. 
 
The presence of some inclusion or exclusion criteria cannot be detected by 
preoperative clinical or radiologic evaluations and it is only after the surgeon has 
inserted the arthroscope to inspect the knee joint visually that the presence of such 
injuries or disorders can be detected. Consented subjects will only be enrolled at the 
time of arthroscopy provided a qualifying meniscal tear is confirmed, no other 
exclusionary findings are encountered and the meniscal tear is surgically treated. 
 
b. 
Inclusion Criteria 
 
Screening Inclusion Criteria:  
Subjects of either gender may be eligible for inclusion in the study only if they meet 
all of the following criteria:  
 Able and willing to give informed consent by voluntarily providing written 
informed consent in accordance with governing Institutional Review Board 
 18 to 60 years of age, inclusive at the time of screening; 
 History indicative of meniscal pathology (e.g., pain, mechanical symptoms 
described as locking, clicking or giving way); 
 Physical exam consistent with meniscus tear (e.g., locked joint, joint line 
tenderness and/or pain on meniscal compression); 

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 If prior ligament reconstruction, the study knee is clinically stable; 
 Preoperative MRI evidence within 6 months consistent with a 
horizontal/oblique meniscus tear in the symptomatic compartment 
 Healthy and not pregnant 
 
Arthroscopy Inclusion Criteria: 
Consented subjects may be included in the study only if, upon arthroscopic 
inspection, their meniscal study lesion meets all of the following criteria established 
by the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports 
Medicine (ISAKOS) (see Appendix 1):  
 Zone location: circumferential location of tear includes locations within 
10mm of the peripheral rim of the meniscus; 
 Radial location: any location from anterior to posterior; 
 Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 
degrees from horizontal); 
 Compartment: either lateral or medial, but not both; 
 Opposite compartment meniscal tear (if present) limited to the central 
portion (i.e., Zone 3/“white zone”); 
 Tear amenable to repair with all suture-based techniques. 
 
c. 
Exclusion Criteria 
 
Screening Exclusion Criteria: 
Subjects will be excluded from the study for any of the following reasons:  
 Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See 
Appendix 4]); 
 Body Mass Index (BMI) ≥35 kg/m2; 
 Previous meniscal repair or meniscectomy of the study meniscus; 
 Unstable knee; 
 Malalignment (> 5 degrees) of the study knee, based on X-ray within 6 
months requiring osteotomy and/or requiring correction; 
 History of constitutional/systemic inflammatory/arthritic problem or pain 
condition, history of knee infection, vascular condition of legs, benign 
neoplasms of knee, hepatitis, HIV, drug/alcohol abuse, tobacco abuse, cancer; 
 Expected to undergo any other primary treatment of the knee; 
 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. 
 Pregnant or planning to become pregnant in the next 2 years. 
 
 
Arthroscopy Exclusion Criteria: 
Subjects will be excluded from the study if their study meniscus lesion meets any of 
the following criteria at arthroscopy: 

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 Tear pattern: primarily vertical longitudinal or radial in orientation; 
 Partial meniscectomy of any portion of the study meniscus extends beyond 
the central portion (i.e., Zone 3/“white zone”); 
 Intact or partially intact meniscus tear that, in the opinion of the Investigator, 
does not require repair; 
 Poor meniscal tissue quality such that it will not hold a suture; 
 Any portion of the meniscus repair that, in the opinion of the Investigator, is 
best treated using an implant other than suture; 
 Clinically significant (zone 1 and/or zone 2) tear in the contralateral 
compartment to the study meniscus; 
 Performance of a significant concomitant procedure intended as a 
therapeutic intervention on the study knee; 
 Arthritis in the surgical knee Modified Outerbridge Grade III or higher [See 
Appendix 2 and 3]). 
 
5.3. 
Withdrawal Criteria  
Subjects may withdraw from the study at any time prior to the subject’s expected 
completion and for any reason without prejudice to further treatment.  Subjects 
considered treatment failures will be withdrawn from the study to receive 
appropriate alternative treatment. 
 
A subject’s participation in the study may be discontinued at any time prior to the 
subject’s expected completion at the discretion of the Investigator or Sponsor.  
Reasons for removing a subject from the study include, but are not limited to, the 
following: 
 The subject is uncooperative in adhering to the protocol requirements, 
including failure to participate in rehabilitation; 
 The Investigator believes it is in the best interests of the subject; 
 The subject withdraws consent. 
 
The Investigator will attempt to document the subject’s reason for withdrawal on 
the study completion CRF. 
 
If a subject fails to attend study visits, every attempt shall be made to contact the 
subject prior to considering the subject lost to follow up and withdrawing the 
subject from the study. 
 
Subjects who are withdrawn from the study will not be replaced. 
 
6. 
METHODS AND PROCEDURES 
 
6.1. 
Method for Assigning Subjects  
This trial is a single-arm, nonrandomized, open label study; assignment and blinding 
procedures are not required. 

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6.2. 
Study Visits and Procedures 
The schedule of events for subjects in this study is shown in Section 14.  Subjects 
will be followed a total of 2 years following the index procedure.  The study will 
close when the last subject entering the trial has completed the last study follow-up. 
 
a. 
Screening Visit (Study Visit 1); within 4 weeks of the procedure 
Subjects will be preliminarily screened for inclusion in the study when the 
Investigator evaluates them for knee pain.  If a subject qualifies for inclusion in the 
study by meeting all of the screening inclusion criteria and meeting none of the 
exclusion criteria, then the study procedure, including the risks and benefits of 
participation, will be discussed with the subject.  If the subject consents to 
participate, written informed consent with the Subject Informed Consent Form (see 
Appendix 5) will be obtained prior to initiating any tests or assessments not 
otherwise considered standard-of-care for the condition for which he or she is being 
evaluated. 
 
The Subject will be provided with a copy of the signed Subject Informed Consent 
Form.  The original will be kept in a secure location at the study site.  If the Subject is 
subsequently enrolled in the study, a copy of the Subject’s signed Subject Informed 
Consent Form will be placed in the Subject’s study binder along with completed 
CRFs.  Study binders will be stored in a secure location.  In order to maintain Subject 
confidentiality, the Sponsor will not receive a copy of the signed Subject Informed 
Consent Form and will rely on the Investigator to ensure that ALL Subjects have 
reviewed and signed the Subject Informed Consent Form prior to collecting any 
study-directed information or undergoing any study-directed treatment.      
 
If a subject qualifies for inclusion in the study by meeting all of the screening and 
preoperative baseline clinical inclusion criteria and meeting none of the pre-
arthroscopy exclusion criteria, the subject will be provisionally enrolled and 
scheduled for arthroscopy.  The subject’s demographic information relevant to 
study variables will be collected at the Screening Visit.  Subjects will also complete 
KOOS, IKCD Subjective Knee Evaluation, Lysholm Knee Questionnaire and Tegner 
Activity Scale outcome assessments. 
 
b. 
Surgery and Rehabilitation (Study Visit 2) 
 
Arthroscopy Procedure 
Investigator-specific standard-of-care arthroscopy will be performed.  
Intraoperative eligibility criteria will be evaluated.  If all of the arthroscopy 
inclusion criteria are met and none of the arthroscopy exclusion criteria are met, the 
subject will be eligible for study enrollment. The subject is officially enrolled in the 
trial when the meniscal repair is completed. 
 
Meniscal Repair Procedure 

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The Investigator will follow standard all-inside and/or inside-out, and/or outside-
in, and/or NovoStitch arthroscopic procedures: 
 Recommended spacing of sutures is 5mm;   
 Video, still photographs and diagrams of the arthroscopy procedure will be 
captured for documentation of meniscal tear, tear preparation and tear 
treatment parameters.  Images and diagrams will be provided to the sponsor.  
All patient identifying information should be removed prior to transferring 
images to the sponsor.  
 
The ISAKOS Questionnaire documenting details of the meniscus tear and required 
excision (if any) will be completed (CRF-004, Details of Pathology).  Details of the 
procedure will be documented (CRF-005, Details of Procedure) will be completed.  It 
contains questions regarding the following: 
 Number and configuration of sutures used; 
 Repair technique and instruments; 
 Meniscal repair time recorded from intraarticular introduction of suture to 
transection of final suture knot; 
 Other intraoperative findings. 
 
Rehabilitation Procedure 
All subjects will follow their Investigator’s preferred rehabilitation plan based on 
the particular tear and repair characteristics. At a minimum, all subjects must meet 
the following post-operative thresholds: 
 Weight bearing as tolerated 
 Hinged knee brace locked in extension when walking (4-6 weeks), released 
to 90 degrees for sitting/driving 
 No squatting or stand up/sit down motions until after 6 weeks post-op 
 No cutting or pivot sports until after 6 months post-op 
 
c. 
First Follow-up [7-15 days] (Study Visit 3) 
Subjects will be evaluated and a safety follow-up will be completed. 
 
d. 
Second Follow-up [90 Day ± 7 days] (Study Visit 4) 
All subjects will be evaluated and a safety follow-up form will be completed.  In 
addition all subjects will complete the following: 
 KOOS 
 IKCD Knee Evaluation 
 Lysholm Knee Questionnaire 
 Tegner Activity Scale 
 
e. 
Third Follow-up [185 Day ± 14 days] (Study Visit 4) 
All subjects will be evaluated, and a safety follow-up form will be completed.  In 
addition all subjects will complete the following: 
 KOOS 

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 IKCD Knee Evaluation 
 Lysholm Knee Questionnaire 
 Tegner Activity Scale 
 
Where available, subjects will undergo an in-office arthroscopy (i.g.VisonScope) to 
assess the tissue repair. Clinical follow-up should continue with or without the 
arthroscopy. 
 
f. 
Fourth Follow-up [365 Day ± 30 days] (Study Visit 5) 
All subjects will be evaluated, a safety follow-up form will be completed and an MRI 
will be performed.  In addition all subjects will complete the following: 
 KOOS 
 IKCD Knee Evaluation 
 Lysholm Knee Questionnaire 
 Tegner Activity Scale 
 
g. 
Fifth Follow-up [730 Day ± 30 days] (Study Visit 6) 
All subjects will be evaluated, a safety follow-up form will be completed and a 
Standing AP x-ray will be obtained for evaluation of joint space narrowing.  In 
addition all subjects will complete the following: 
 KOOS 
 IKCD Knee Evaluation 
 Lysholm Knee Questionnaire 
 Tegner Activity Scale 
 
 
7. 
SAFETY MEASUREMENTS 
 
7.1. 
Definitions 
 
Complication 
A complication is any untoward medical occurrence, unfavorable and unintended 
sign (including clinically significant abnormal laboratory finding), symptom, or 
condition experienced by the subject and temporally associated with the procedure 
whether or not considered related to the procedure. 
 
Major Complication 
Any complication attributable to the meniscal repair procedure that, in the view of 
either the Investigator or Sponsor, results in any of the following outcomes: 
 Death; 
 Life-threatening illness or injury; 
 Inpatient hospitalization or prolongation of existing hospitalization; 
 Persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions; 

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 Important medical events that, based upon appropriate medical judgment, 
require medical or surgical intervention to prevent one of the above 
outcomes. 
 
7.2. 
Collecting, Recording and Reporting of Complications 
At each contact with the subject, the Investigator will seek information on 
complications by specific questioning and, as appropriate, by examination.  All 
complications definitely, probably or possibly involving the treated knee, as well as 
any required remedial action shall be recorded on the subject’s appropriate CRF.  
The investigator will also be asked to assess the complication with respect to 
severity and relatedness to the procedure. 
 
The minimum initial information to be captured in the subject’s source document 
concerning the complication includes:  
 Study identifier; 
 Study center; 
 Subject number; 
 A description of the complication; 
 Date of onset; 
 Investigator assessment of the association between the complication and 
study treatment (relatedness); 
 Investigator assessment of severity; 
 Current status; 
 Whether the complication is a major complication and reason for this 
classification. 
 
The clinical course of each complication should be recorded and followed until 
resolution, stabilization, or until it has been determined that the surgical repair is 
not the cause. 
 
Notification of Sponsor by Investigator 
The Investigator shall notify the Sponsor of any Major Complication experienced by 
any subject entered into the study.  Such Major Complications must be reported 
within 24 hours to the following: 
 
 
 
 
 
 
 
 
 
 
 
Ceterix Orthopaedics 
959 Hamilton Avenue 
Menlo Park, CA 
(650) 316-8660 
jmccutcheon@ceterix.com 

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Within the following 48 hours, the Investigator shall provide further information, as 
applicable, in the form of a written narrative.  As the Investigator learns it, 
significant new information shall be provided on an ongoing basis to the Sponsor. 
 
Notification of IRB by Investigator 
With one exception noted at the end of Section 7.2, all communication with an IRB is 
the responsibility of the Investigator.  Investigator will comply with all IRB 
requirements for the reporting of complications.  Copies of each report and 
documentation of IRB notification and receipt will be kept in the Investigator’s 
study file. 
 
An Investigator shall report to the Sponsor a withdrawal of approval by the 
Investigator’s reviewing IRB as soon as a possible, but no later than 5 working days 
of the IRB notification of withdrawal.   
 
Notification of Investigators and IRBs by Sponsor 
 
The Sponsor shall notify all participating IRBs and participating Investigators of any 
withdrawal of approval of the study by a reviewing IRB within 5 working days after 
receipt of the withdrawal of approval. 
 
7.3. 
Study Monitoring Plan, Auditing, and Inspecting 
 
a. 
Study Monitoring Plan 
The Investigator will allocate adequate time for any monitoring activities deemed 
appropriate by the Sponsor.  The Investigator will also ensure that the monitor or 
other compliance or quality assurance reviewer is given access to all study-related 
documents and study-related facilities (e.g., examination rooms, radiology facility, 
operating room, etc.), and has adequate space to conduct the monitoring visit. 
 
b. 
Medical Monitoring 
It is the responsibility of the Investigator to oversee the safety of the study at 
his/her site.  This safety monitoring will include careful assessment and appropriate 
reporting of complications as noted in Section 7.2. 
 
c. 
Auditing and Inspecting 
The Investigator will permit study-related monitoring, audits, and inspections by 
the IRB, the Sponsor, government regulatory bodies, and University compliance and 
quality assurance groups of all study-related documents (e.g., source documents, 
regulatory documents, data collection instruments, study data, etc.).  The 
Investigator will ensure the availability for inspections of applicable study-related 
facilities (e.g., examination rooms, surgical facility, etc.). 
 

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In the course of normal study conduct or as revealed in a site monitoring or audit 
visit, any deviations from the protocol will be documented and as needed corrective 
action(s) will be initiated. 
 
 
8. 
DATA HANDLING AND RECORD KEEPING 
 
8.1. 
Data Quality Assurance 
Data quality is the responsibility of the Investigator.  CRF completion may be 
delegated to other study personnel but the Principal Investigator remains 
responsible for the accuracy and integrity of all data entered on CRFs. CRFs will be 
completed and provided to the Sponsor or its designated representative as directed, 
in an expedited fashion. The Sponsor will work with participating sites to secure 
data clarification and to obtain additional relevant medical documentation on 
participants enrolled into this trial. 
 
8.2. 
Confidentiality 
Information about study subjects will be kept confidential and managed according 
to the requirements of the Health Insurance Portability and Accountability Act of 
1996 (HIPAA).  Those regulations require a signed subject authorization informing 
the subject of the following:  
 What protected health information (PHI) will be collected from subjects in 
this study; 
 Who will have access to that information and why; 
 Who will use or disclose that information; 
 The rights of a research subject to revoke authorization for use of one’s PHI.  
 
Case report forms will utilize an anonymous subject identifier.  The identifier will be 
composed of the site study ID number, the first letter of the subject’s first name, the 
first letter of the subject’s last name, and a sequential subject number by site.   
 
Example:  The subject identifier for the fourth-enrolled subject at site 02, 
whose name is Jane Doe, would be 02-JD-04. 
 
The Investigator is responsible for ensuring that all CRFs and any other documents 
or media, such as arthroscopic video or still photos, are de-identified prior to 
sharing with Sponsor.   
 
In the event a subject revokes authorization to collect or use PHI, the Investigator, 
by regulation, retains the ability to use all information collected prior to the 
revocation of subject authorization.  For subjects who have revoked authorization to 
collect or use PHI, attempts should be made to obtain permission to collect at least 
vital status at the end of their scheduled study period. 
 

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8.3. 
Source Documents 
Source data is all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of 
the trial.  Source data are contained in source documents.  Examples of these 
original documents, and data records include: hospital records, clinical and office 
charts, laboratory notes, memoranda, physician-completed study forms, recorded 
data from automated instruments, copies or transcriptions certified after 
verification as being accurate and complete, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, 
at the laboratories, and at medico-technical departments involved in the clinical 
trial. 
 
8.4. 
Case Report Forms (see Appendix 6) 
The study case report form (CRF) is the primary data collection instrument for the 
study.  All data requested on the CRF must be recorded.  All missing data must be 
explained.  If a space on the CRF is left blank because the procedure was not done or 
the question was not asked, “N/D” will be entered.  If the item is not applicable to 
the individual case, “N/A” will be entered.  All entries should be printed legibly in 
black ink.  If any entry error has been made, to correct such an error, a single 
straight line will be drawn through the incorrect entry and the correct data will be 
entered above it.  All such changes must be initialed and dated.  Errors will not be 
erased or obliterated (i.e. use of Wite-out).  For clarification of illegible or uncertain 
entries, clarification may be printed above the item, initialed and dated. 
 
8.5. 
Retention of Trial Documents and Records 
Trial documents and records are to be retained at least until 2 years following the 
official end of the study at all sites. 
 
9. 
STATISTICAL PLAN 
  
9.1. 
Subject Population(s) for Analysis 
Data obtained from all enrolled subjects will be analyzed on a per-treatment (PT) 
basis, which will include all enrolled subjects who receive the protocol-defined 
treatment of suture-based meniscal repair. 
 
9.2. 
Statistical Methods 
Appropriate descriptive statistics will be presented for baseline characteristics, 
procedural variables, reoperation rate of the index meniscal repair site, and major 
complications.  Logistic regression will be fitted to determine baseline predictors of 
various outcome measures.  Independent variables for these models will include but 
may not be limited to, tear compartment, circumferential length of tear, primarily 
horizontal vs. oblique, subject age, subject gender, subject BMI, study site, partial 
meniscectomy vs. no meniscectomy, meniscal surgical technique.   
 

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Justification for data pooling will be made on a clinical basis.48 These criteria call for 
use of the same protocol requirements at all sites, the sponsor to monitor the sites 
for compliance with the protocol, and the use of similar data collection procedures 
at all sites.  Since this study does not include a control group, no analysis of the 
interaction of the treatment effect with clinical site is possible. Reoperation rates 
will be evaluated by clinical center. 
 
Subject and reported outcome measures, KOOS, IKCD Knee Evaluation, Lysholm 
Knee Questionnaire and Tegner Activity Scale outcome assessments will be 
summarized and thoroughly characterized across time with the appropriate 
descriptive statistics including error measures.  Statistics may include mean, mode, 
median, range, inter-quartile range, minimum, maximum and frequency, cumulative 
frequency percentage and cumulative percentage.  Results will be presented in 
narrative and graphically. 
These measures will also be analyzed using inferential statistics.  As appropriate a 
repeated measure ANOVA or Wilcoxon signed rank test will be completed for each 
outcome measure.  If a significant trend is identified, significance among time points, 
especially preoperative measures, may be further explored using the appropriate 
pair-wise comparisons.  In all cases a p value equal to or less than 0.05 will be 
considered significant. 
 
10. ETHICAL CONSIDERATIONS 
 
10.1. IRB Review 
This protocol and any amendments will be submitted to a properly constituted 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for 
formal approval of the study conduct.  The decision of the IRB concerning the 
conduct of the study will be made in writing to the Investigator and a copy of this 
decision will be provided to the Sponsor before commencement of this study.  The 
Investigator should provide a list of IRB members and their affiliate to the Sponsor. 
 
10.2. Informed Consent 
All subjects for this study will be provided a Subject Informed Consent Form 
describing this study and providing sufficient information for subjects to make an 
informed decision about their participation in this study.  This consent form will be 
submitted with the protocol for review and approval by the IRB for the study.  The 
formal consent of a subject, using the IRB-approved consent form, must be obtained 
before that subject undergoes any study procedure.  The subject must sign and date 
the consent form.  No surrogate for the subject may sign on the subject’s behalf. 
 
11. CONFLICT OF INTEREST 
Investigators who have a conflict of interest with this study (e.g., patent ownership, 
royalties, or financial gain greater than the minimum allowable by their institution, 

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etc.) must have the conflict reviewed by a properly constituted Conflict of Interest 
Committee with a Committee-sanctioned conflict management plan that has been 
reviewed and approved by the Sponsor prior to participation in this study.   
 
12. PUBLICATION PLAN 
Sponsor-selected Principal Investigators will facilitate the publication of the results 
(in part or in whole) of the study.  Neither the complete nor any part of the results of 
the study carried out under this protocol, nor any of the information provided by 
the Sponsor for the purposes of performing the study, will be published or passed 
on to any third party without the consent of the Sponsor. Any Investigator involved 
with this study is obligated to provide the Sponsor with complete test results and all 
data derived from the study. Interim study results may be presented or published 
after each study interval. 
 
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meniscal repair results using 3 different meniscal repair devices in anterior 
cruciate ligament reconstruction patients. Arthroscopy. 2008;24(7):810-6. 
45. Binfield PM; Maffulli N; King JB. Patterns of meniscal tears associated with 
anterior cruciate ligament lesions in athletes. Injury. 1993;24(8):557-61. 

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46. Ferrer-Roca O; Vilalta C. Lesions of the meniscus. Part II: Horizontal cleavages 
and lateral cysts. Clin Orthop Relat Res. 1980;146:301-7. 
47. Fetzer GB; Spindler KP; Amendola A; Andrish JT; Bergfeld JA; Dunn WR; 
Flanigan DC; Jones M; Kaeding CC; Marx RG; Matava MJ; McCarty EC; Parker RD; 
Wolcott M; Vidal A; Wolf BR; Wright RW. Potential market for new Meniscus 
repair strategies: evaluation of the MOON cohort. J Knee Surg. 2009;22(3):180-
6. 
48. Meinert, C; Tonascia S. Clinical trials: Design, conduct, and analysis.  Oxford 
University Press, New York, 1986. 
 
 

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14. STUDY ACTIVITY SCHEDULE 
STUDY ACTIVITY SCHEDULE 
Activity 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Screen 
< 4 weeks 
Procedure 
7-15 
Days 
90 Day 
±7 days 
185 Day 
±14 days 
365 Day 
±30 days 
730 Day 
±30 days 
Informed consent 
X 
 
 
 
 
 
 
Screening Inclusion / 
Exclusion 
X 
 
 
 
 
 
 
Demographics / 
Medical History 
X 
 
 
 
 
 
 
Radiographs 
X1,5 
 
 
 
 
 
X1 
MRI 
X5 
 
 
 
 
X2 
 
Images 
 
X3 
 
 
 
 
 
Arthroscopy 
Inclusion / Exclusion  
 
X 
 
 
 
 
 
Study Procedure 
 
X 
 
 
 
 
 
Details of Procedure 
 
X 
 
 
 
 
 
Details of Pathology 
 
X 
 
 
 
 
 
Safety Follow-Up 
 
 
X 
X 
X 
X 
X 
KOOS 
X 
 
 
X 
X 
X 
X 
IKDC Subjective 
X 
 
 
X 
X 
X 
X 
Lyshlom 
X 
 
 
X 
X 
X 
X 
Tenger 
X 
 
 
X 
X 
X 
X 
In-office 
Arthroscopy 
 
 
 
 
X4 
 
 
 
1Standing AP X-ray 
2MRI 1.5 T or greater, no contrast to be reviewed by independent radiologist appointed by 
sponsor. 
3Video, still photographs and diagrams of procedure.  
4If available. 
5 Within 6 months of Procedure 

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15. LIST OF ATTACHMENTS 
 
Appendix 1 
 
ISAKOS Criteria 
Appendix 2 
 
Cartilage Guidance 
Appendix 3 
 
Modified Outerbridge Scale 
Appendix 4 
 
Kellgren-Lawrence Grading Scale 
Appendix 5 
 
Subject Informed Consent Form  
Appendix 6 
 
Case Report Forms 
 001 
Screening Inclusion Exclusion 
 002 
Demographics and History 
 003 
Arthroscopy Inclusion Exclusion 
 004 
Details of Pathology 
 005 
Details of Procedure 
 006 
Safety Follow-Up 
 007 
Complication 
 008 
Details of Reoperation 
 009 
Study Completion 
 010 
Protocol Deviation 
 011 
Data Clarification 
 012 
KOOS 
 013 
IKDC Subjective Knee Evaluation 
 014 
Lysholm Knee Questionnaire 
 015 
Tegner Activity Scale 
 016 
Meniscus Repair Assessment 
 
Appendix 7 
 
Imaging Guidance