A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)
Phase: NA
Conditions: Wound Closure
Sponsor: Johnson & Johnson Medical, China

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
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The information in this document contains trade secrets and commercial information that are privileged or 
confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. 
In any event, persons to whom the information is disclosed must be informed that the information is 
SULYLOHJHG or FRQILGHQWLDO and may not be further disclosed by them. These restrictions on disclosure will 
apply equally to DOO future information supplied to you which is indicated as SULYLOHJHG or FRQILGHQWLDO. 
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Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
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Protocol Writer/Local Medical Monitor 
Medical Affair Manager 
Johnson & Johnson Medical 
(Shanghai) Ltd. 
Zhu Qing 
Medical Affairs Department Head 
Director 
Johnson & Johnson Medical 
(Shanghai) Ltd. 
Li Wan
Clinical Research Department Head  
Associate Director 
Johnson & Johnson Medical 
(Shanghai) Ltd.
Liu Fenghua
Biostatistician  
Biostatistics Director 
Lesko James 
Global Medical Monitor 
Franchise Medical Director 
Schmitz Niels-
Derrek 
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This study will be conducted in compliance with the Declaration of Helsinki as well as all applicable local regulations. 
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Zhu Qing
Li Wan
Liu Fenghua
Lesko James 
Schmitz Niels-
Derrek 
Johnson & Johnson Medical
(Shanghai) Ltd. 
Johnson & Johnson Medical
(Shanghai) Ltd. 
Johnson & Johnson Medical
(Shanghai) Ltd.

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
INVESTIGATOR SIGNATURE 
I have read, understood, and agree to: 

Ensure that the requirements for obtaining informed consent are met;

Conduct the study in accordance with this protocol, including applicable local laws and
regulations;

Maintain the confidentiality of all information received or developed in connection with
this protocol;

Report all serious adverse events as soon as possible, but no later than 24 hours after
becoming aware of the event;

Adhere to the publication policy, as stated in the Clinical Study Agreement, for data
collected during this study; and

Ensure that all associates, colleagues, and employees assisting in the conduct of the
study are informed of their obligations in meeting the above commitments.
I will be responsible for the initial and continuing review and approval of the clinical 
investigation.  I also agree to promptly report to the EC all changes in the research activity and 
all unanticipated problems involving risks to human subjects or others.  Additionally, I will not 
make any changes in the research without Sponsor and EC approval of an amended protocol, 
except where necessary to eliminate apparent immediate hazards to human subjects. 
I agree to comply with all other requirements regarding the obligation of clinical investigators 
and all other pertinent requirements of the Sponsor and government agencies. 
 Investigator Signature 
Date 
Printed Name of Investigator 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
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A Prospective, Multicenter, Randomized Controlled Study to 
Evaluate the Wound Closure Efficiency of STRATAFIX™ 
Symmetric PDS™ Plus Knotless Tissue Control Device 
(STRATAFIX Symmetric PDS Plus) Compared to 
Conventional Sutures in Total Knee Arthoplasty (TKA) 
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ESC-16-001 
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Post-Marketing 
All wound closure products used in the study are legally 
market in China and should be used within their approved 
indications. 
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STRATAFIX™ Symmetric PDS™ Plus Device is indicated for 
use in soft tissue approximation where the use of absorbable 
sutures is appropriate. 
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The primary objective of this prospective, randomized 
controlled study is to evaluate the wound closure efficiency of 
STRATAFIX Symmetric PDS Plus compared to conventional 
sutures in patients undergoing TKA. For the purpose of this 
study, wound closure efficiency is defined as the total time 
required to close the surgical incisions in patients undergoing 
TKA procedures using STRATAFIX Symmetric PDS Plus 
compared to those using traditional sutures. Secondary 
objectives will include the evaluation of differences in overall 
surgical procedure time, operating room (OR) time, length of 
stay, procedure costs, quality of life measures including pain, 
and range of motion (ROM). In addition, the difference in the 
safety profiles for both wound closure procedures will be 
evaluated through the analysis of the incidence of wound 
complications including dehiscence, wound infections, and 
other adverse events. 
y
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Symmetric PDS™ Plus 
(STRATAFIX Symmetric PDS Plus)
y
STRATAFIX™ Symmetric PDS™ Plus
y
STRATAFIX Symmetric PDS Plus 
g
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 STRATAFIX Symmetric PDS Plus

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
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Primary Efficacy Endpoints: 
The primary endpoint will be the total time required to close 
the surgical incisions between treatment groups. The time to 
close each surgical incision is defined as the time in minutes 
between placement of the first suture throw in the deep tissue 
and the completion of intradermal layer closure (capturing the 
suturing time only). 
Secondary Efficacy Endpoints: 
1.
Duration of procedure;
2.
Overall OR time;
3.
Length of stay between surgery and discharge; and
4.
TKA related QoL assessments:
a.
Knee pain;
b.
Health-related quality of life (EQ-5D-3L);
Secondary Safety Endpoints: 
1.
The incidence of surgical site infection (SSI) following
surgery as defined by CDC criteria;
2.
ASEPSIS score (only for subjects with confirmed SSI);
3.
Acute Inflammatory Response Evaluation (AIRE) score;
4.
Incidence of wound separation or dehiscence requiring
intervention;
5.
Incidence of delayed wound healing events; and
6.
Incidence of adverse events (AEs) and serious adverse
events (SAEs) associated with wound closure;
6WXG\'HVLJQ
This is a multicenter, single blind, prospective, randomized 
controlled study in patients undergoing elective TKA and 
meeting the study’s eligibility criteria. Eligible patients will be 
randomized on 1:1 basis to have the surgical incision closed 
with either STRATAFIX Symmetric PDS Plus or conventional 
sutures. Wound closure and surgical procedure times will be 
determined perioperatively. Patients will remain blinded to the 
type of sutures utilized for closure of the incision. 
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184 subjects (92 per arm) 
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Enrollment is anticipated to require approximately 8 months. 
The duration of the study is therefore expected to be 
approximately 9 months from the date of the first patient 
enrolled to the last patient taking into account the 4-6 weeks 
follow-up period. 
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1.
Patient is  18 years and < 80 years of age;
2.
Patient with osteoarthritis is scheduled to undergo
elective unilateral TKA;
3.
Patient is willing to participate in the study, comply with
study requirements, follow-up schedule, and give written
informed consent; and
4.
Patient agrees not to schedule any additional elective
surgical procedures until participation in this study is
complete.
g
r STRATAFIX Symmetric PDS Plus 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
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1.
Female patient who is pregnant or lactating at the time of
screening;
2.
Patient has a Body Mass Index (BMI) > 40 kg/m2;
3.
Patient is not able to walk independently (inability to walk
at least 10 consecutive meters without a walking aid);
4.
Patient has had a surgical intervention during the past 30
days for treatment of painful joint or its underlying
etiology;
5.
Patient has had previous open surgeries on the affected
joint other than arthroscopy;
6.
Patient has active infectious collagen diseases (i.e.
scleroderma) or any other condition that would interfere
with wound healing;
7.
Patient is allergic to poly (p-dioxanon), IRGACARE®*
MP (triclosan) or D&C Violet No. 2;
8.
Patient has diabetes with poor control, defined as fasting
plasma glucose (FPG)  10.0 mmol/L;
9.
Patient has a history of immunosuppressive drug use,
including steroids, within the last 6 months;
10. Patient has undergone chemotherapy or radiation within
the last 6 months prior to study enrollment or is
scheduled to do so during the study period;
11. Patient has known personal or family history of keloid
formation or hypertrophy;
12. Patient has other dermatologic conditions known to
impair wound healing;
13. Patient is participating in any other investigational drug
(within 30 days or 5 half-lives of an investigational drug)
or device study;
14. Patient has any physical or psychological condition which
would impair study participation; and
15. Patient is judged unsuitable for study participation by the
investigator for any other reason.
6WXG\3URGXFW
STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue 
Control Device
STRATAFIXTM Symmetric PDSTM Plus 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
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All efficacy endpoints will be summarized descriptively by 
treatment group. The continuous variables will be summarized 
descriptively by number of subjects, mean, standard deviation, 
minimum, and maximum. Categorical data will be summarized 
descriptively by frequencies along with the associated 
percentages. 
In addition, for the primary efficacy endpoint, a one-sided 
97.5% confidence interval for the difference in treatment group 
means (Mean STRATAFIX Symmetric PDS Plus closure time 
minus the Mean closure time for conventional suture) will be 
constructed using the t-distribution. 
The primary efficacy endpoint will be analyzed using the mITT 
and Per-Protocol analysis sets. The ITT analysis will be 
considered as the primary analysis. All secondary efficacy 
endpoints will be analyzed using the mITT analysis set. 
All secondary safety endpoints will be summarized descriptively
by treatment group for the Safety analysis set using available 
data. The continuous variables will be summarized 
descriptively by number of subjects, mean, standard deviation, 
minimum, and maximum. Categorical data will be summarized 
descriptively by frequencies along with the associated 
percentages. No inferential statistics will be generated for the 
secondary safety endpoints. 
 STRATAFIX Symmetric PDS Plus 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
SCHEDULE OF EVENTS 
Event 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Baseline/ 
Screeninga 
Randomization
Procedure 
Post-Op 
through 
Dischargeb 
30-42 daysc 
(post 
procedure) 
Informed consent 
X 
IWRS/IVRSd
X
Inclusion/Exclusion Criteria 
X 
X 
Urine/blood pregnancy test 
X 
Demographics
X
Medical/Surgical history 
X 
X 
Physical examinatione
X
X
X
Knee pain VAS 
X 
X 
X 
EQ-5D-3L
X
 
X 
X
Concomitant medicationsf
X
X
X
X
X
Length of stayg
 
X
Health Economic Data 
Collection 
X
Procedural datah 
X
Adverse events 
X 
X 
X 
Wound complication 
assessment 
X
X
X
SSI/ASEPSIS scorei
X
X
AIRE score 
X 
X 
Study completion 
X 
a.
To be performed within 30 days of surgery. 
b.
Physical examination, knee pain VAS, EQ-5D-3L and  AIRE score  will be collect on 3-5 days after surgery. 
c.
Unless withdrawn from the study, subject’s status will be confirmed at the time of in-person visit at 30-42 days following surgery. If 
possible, an in-person visit will be scheduled to confirm status for patients withdrawn prematurely from the study for any reason. 
d.
Interactive web response system/ Interactive voice response system.
e.
The physical examination at baseline/screening visit includes height, weight and ROM of knee, and the post-procedure physical
examination only includes ROM of knee. 
f.
Including pain medications and antibiotics (except for anesthesia medications).
g.
Defined as time between procedure and discharge.
h.
Procedure time, overall OR time, intra-operative device failure rates, operating room resource utilization (if applicable), and 
anesthesia method (e.g., general or lumbar anesthesia).
i.
ASEPSIS score will be applied only after SSI confirmed. 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
TABLE OF CONTENTS 
Page 
INVESTIGATOR SIGNATURE ................................................................................................. 3 
SYNOPSIS ................................................................................................................................ 4 
SCHEDULE OF EVENTS ......................................................................................................... 8 
PROTOCOL-SPECIFIC ACRONYMS AND ABBREVIATIONS ............................................ 11 
1.0 
Introduction .................................................................................................................... 12 
1.1 
Knee Joint Disorder and TKA .................................................................................... 12 
1.2 
Study Device Description .......................................................................................... 12 
2.0 
Study Objectives ........................................................................................................... 13 
2.1 
Primary Endpoints: .................................................................................................... 13 
2.2 
Secondary Efficacy Endpoints: ................................................................................. 13 
2.3 
Secondary Safety Endpoints: .................................................................................... 17 
3.0 
Investigational Plan ....................................................................................................... 20 
3.1 
Overall Study Design and Plan-Description.............................................................. 20 
3.2 
Study Population ....................................................................................................... 20 
3.2.1 
Inclusion Criteria ................................................................................................... 20 
3.2.2 
Exclusion Criteria .................................................................................................. 20 
3.2.3 
Removal of Subjects from Study .......................................................................... 20 
3.3 
Study Procedure ........................................................................................................ 21 
3.3.1 
Procedure Description .......................................................................................... 21 
3.3.2 
Blinding ................................................................................................................. 23 
3.3.3 
Subject Compliance .............................................................................................. 23 
3.4 
Study Procedures ...................................................................................................... 23 
3.4.1 
Visit 1 – Baseline Visit .......................................................................................... 24 
3.4.2 
Visit 2 – Randomization ........................................................................................ 24 
3.4.3 
Visit 3 – Surgical Procedure ................................................................................. 24 
3.4.3.1 
Pre-procedure ................................................................................................ 24 
3.4.3.2 
Intraoperative ................................................................................................. 25 
3.4.4 
Visit 4 – Post-Op through Discharge .................................................................... 25 
3.4.5 
Visit 5 – 30-42 Days .............................................................................................. 25 
4.0 
Data Management and Integrity .................................................................................... 26 
4.1 
Data Completion and Record Keeping ..................................................................... 26 
4.1.1 
Source Documents ............................................................................................... 26 
4.1.2 
Electronic Data Capture ........................................................................................ 26 
4.1.3 
Data Collection ...................................................................................................... 26 
4.1.4 
Data Correction ..................................................................................................... 27 
4.1.5 
Data Privacy .......................................................................................................... 27 
4.1.6 
Record Retention, Inspection, and Custody ......................................................... 27 
4.2 
Medical Dictionary Coding ........................................................................................ 27 
4.3 
Data Quality Assurance ............................................................................................ 27 
4.3.1 
Monitoring ............................................................................................................. 28 
4.3.2 
Regulatory Requirements ..................................................................................... 28 
4.4 
Protocol Deviations ................................................................................................... 28 
4.5 
Statistical Methods Planned in the Protocol and Determination of Sample Sizes ... 28 
4.5.1 
Statistical and Analytical Plans ............................................................................. 28 
4.5.2 
Determination of Sample Size .............................................................................. 28 
4.5.3 
Analysis Sets ........................................................................................................ 29 
4.5.4 
Analysis of Primary and Secondary Efficacy Endpoints ...................................... 29 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
4.5.5
Analysis of Secondary Safety Endpoints.............................................................. 30
4.6
Statistical/Analytical Issues ....................................................................................... 30
4.6.1
Handling of Dropouts or Missing Data .................................................................. 30
4.6.2
Multicenter Studies ............................................................................................... 30
5.0
Risks and Benefits of the Study Device and Clinical Investigation .............................. 30
6.0
Adverse Event ............................................................................................................... 30
6.1
Definitions .................................................................................................................. 30
6.1.1    Anticipated Adverse Events ................................................................................. 30
6.1.2    Pre-existing Condition .......................................................................................... 30
6.1.3    Adverse Event ...................................................................................................... 31
6.1.4    Expected Morbidity/Anticipated Adverse Events ................................................. 31
6.1.5    Serious Adverse Event ......................................................................................... 31
6.1.6    Adverse Device Effect (ADE) ............................................................................... 31
6.1.7    Serious Adverse Device Effect (SADE) ............................................................... 31
6.1.8    Severity of Adverse Events .................................................................................. 32
6.1.9    Relationship of Adverse Events ........................................................................... 32
6.2
Reporting Adverse Events ........................................................................................ 32
6.3
Reporting Serious Adverse Events ........................................................................... 32
7.0
Product Complaints ....................................................................................................... 32
7.1
Product Complaints Definition ................................................................................... 32
7.2
Reporting Product Complaints .................................................................................. 33
7.3
Reporting Product Complaints for Non-Ethicon Devices .......................................... 33
8.
References .................................................................................................................... 34
-Ethicon 

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Version/Date: Administrative Change 1/27 MAY 2017  
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Acronyms/Abbreviations 
 
Terms 
ADE
 
Adverse Device Effect
AE
 
Adverse Event
AIRE 
Acute Inflammatory Response Evaluation 
ASADE 
Anticipated Serious Adverse Device Effect 
BMI 
Body Mass Index 
CDC 
Centers for Disease Control 
CFDA 
China Food and Drug Administration 
CFR 
Code of Federal Regulations 
CHU 
Complaint Handling Unit 
EC
 
Ethics Committee
eCRF 
Electronic Case Report Form 
ESC 
Ethicon Surgical Care 
EDC 
Electronic Data Capture 
FPG 
Fasting Plasma Glucose 
GCP 
Good Clinical Practice 
ICD
 
Informed Consent Document
mITT
 
modified Intent-to-Treat
IVRS 
Interactive Voice Response System 
IWRS 
Interactive Web Response System 
MedDRA 
Medical Dictionary for Regulatory Activities 
OR
 
Operating Room
PI
 
Principal Investigator
PP
 
Per-Protocol
QoL
 
Quality of Life
ROM
 
Range of Motion
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP
 
Statistical Analysis Plan
SOC
 
Standard of Care
SSI 
Surgical Site Infection 
TKA 
Total Knee Arthoplasty 
TSA 
Topical Skin Adhesive 
USP 
United States Pharmacopeia 
VAS 
Visual Analogue Scale 
Ethicon 

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Version/Date: Administrative Change 1/27 MAY 2017  
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The knee joint is a complicated structure bound by a host of tendonous and ligamentous 
structures prone to acute and chronic injury. Since the hyaline cartilage covered weight bearing 
surfaces are separated by menisci, body weight, impact and trauma gradually draw them together 
over time. Once the joint space is compromised by meniscal thinning, hyaline surfaces come into 
contact with one another, degenerative processes begin and osteoarthritis develops. Other types 
of disease that may affect the knee include rheumatoid arthritis, post-traumatic arthritis, 
osteonecrosis and cancer. Irrespective of the underlying degenerative process, pain and 
decreased range of motion begin to impact the patients’ quality of life. Gradually, fewer daily 
activities are performed and systemic and mental healths are affected.    
First performed in the 1960’s, total knee arthroplasty (TKA) is a historically successful procedure 
that removes diseased portions of the knee joint and replaces them with prosthetic implants. 
Although there are many causes of knee joint deterioration, the primary indication for a patient to 
undergo TKA is to address the pain and loss of joint function secondary to advanced 
osteoarthritis. 
Over the past 20 years, due to ageing, development of diagnostic and surgical technologies, as 
well as the continuous improvement of surgical instruments, the number of TKA surgery 
continues to grow over time [1, 2]. And the number could still continue growing rapidly in the next 
two decades [3-5], and further increasing the burden of health-care institutions. Currently, 
interrupted suture was still in use to close surgical incision during the operation. In comparison to 
the traditional continuous suture technique, interrupted suture may in some degree improve the 
suture strength for the surgical incision, in order to meet the need of early function exercise. 
However, interrupted technique has a relatively low suture efficacy, thus may prolong the suturing 
and operation time, when compared to the continuous technique. Reducing the operation time is 
associated with reduced risk of incisional complications, especially surgical site infection [6], which 
as a result, can be catastrophic for the TKA surgery outcome. STRATAFIX™ Symmetric PDS™ 
Plus have a unique barbed design, which, theoretically, allows physicians to perform highly 
efficient continuous suture, and to improve operation efficiency. By reducing the operation time, 
the new product can achieve the same safety and effectiveness as compared with the interrupted 
suture technique [5, 7-10]. 
This study was designed to verify that STRATAFIX™ Symmetric PDS™ Plus can improve the 
operation efficacy,  can reduce the suturing and operation time as well as meet the clinical 
demand for suture safety, as compared to traditional interrupted suture technique during TKA 
surgery.
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STRATAFIX Symmetric PDS Plus is an antibacterial (polydioxanone) monofilament, synthetic 
absorbable device prepared from polydioxanone (p-dioxanone).The device contains 
IRGACARE®1 MP (triclosan), a broad spectrum antibacterial agent. STRATAFIX Symmetric PDS 
Plus monofilament is dyed with D&C Violet No. 2. STRATAFIX Symmetric PDS Plus consists of 
an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and 
a fixation tab at the other (Figure 1). The anchors and fixation tab design allows for tissue 
approximation without the need to tie surgical knots. The cross-sectional area of the STRATAFIX 
Symmetric PDS Plus core is comparable to the cross-sectional area of a United States 
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Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
Pharmacopeia (USP) suture with the same designation, i.e., 0, 1, 2-0, 3-0. STRATAFIX 
Symmetric PDS Plus straight tensile strength is stronger than the knot tensile strength for a USP 
polydioxanone suture of the equivalent size. Polydioxanone has been found to be non-allergenic, 
non-pyrogenic, and to elicit only a slight tissue reaction during absorption. 
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The primary objective of this prospective, randomized controlled study is to evaluate the wound 
closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in 
patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as 
the total time required to close the surgical incisions in patients undergoing TKA procedures using 
STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary 
objectives will include the evaluation of differences in overall surgical procedure time, operation 
room (OR) time, length of stay, procedure costs, quality of life measures including pain, and 
range of motion (ROM). In addition, the difference in the safety profiles for both wound closure 
procedures will be evaluated through the analysis of the incidence of wound complications 
including dehiscence, wound infections, and other adverse events. 
3ULPDU\(QGSRLQWV
The primary endpoint will be the total time required to close the surgical incisions between 
treatment groups. The time to close each surgical incision is defined as the time in minutes 
between placements of the first suture throws in the deep tissue to the completion of Intradermal 
layer closure (capturing the suturing time only). 
6HFRQGDU\(IILFDF\(QGSRLQWV
1.
Duration of procedure: defined as the time in minutes elapsed from first incision to the skin
closure.
 STRATAFIX
p
(
)
Symmetric PDS Plus 
675$7$),;6\PPHWULF3'63OXV
p
p
f STRATAFIX Symmetric PDS Plus 
q
STRATAFIX Symmetric PDS Plus 

Protocol ESC-16-001
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Version/Date: Administrative Change 1/27 MAY 2017  
2.
Overall operating room (OR) time: defined as the time in minutes from anesthesia to exiting the
OR;
3.
Length of stay between surgery and discharge.
4.
TKA related QoL assessments:
a.
Knee Pain: pain at rest and pain during mobilization is measured using a 10 centimeter
Visual Analogue Scale (VAS) in which patient is asked to describe degree of pain with 0 being no 
pain and 10 being the worst pain. 
b.
Health-related Quality of Life (EQ-5D-3L): patient is asked to confirm his/her health state by
selecting the most appropriate level  for each of the following 5 dimensions. Refer to Table 1. 

Mobility

Self-care

Usual activities

Pain/discomfort

Anxiety/depression

Protocol ESC-16-001
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Table 1: EQ-5D-3L 
By placing a tick in one box in each group below, please indicate which statements best describe 
your own health state today. 
Mobility 
I have no problems in walking about 
 
I have moderate problems in wlaking about 
 
I am unable to walk about 
 
Self-care 
 
I have no problems washing or dressing myself 
 
I have moderate problems washing or dressing myself 
 
I am unable to wash or dress myself 
 
Usual Acitivities (i.e work, study, housework, family or leisure activities) 
I have no problems doing my usual activiites 
 
I have moderate problems doing my usual activiites 
 
I am unable to do my usual activiites 
 
Pain/Discomfort: 
I have no pain or discomfort 
 
I have moderate pain or discomfort 
 
I have extreme pain or discomfort 
 
Anxiety/Depression 
I am not anxious or depressed 
 
I am moderate anxious or depressed 
 
I am extremly anxious or depressed 
 

Protocol ESC-16-001
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To help people say how good 
or bad a health state is, we 
have drawn a scale (rather 
like a thermometer) on which 
the 
best 
state 
you 
can 
imagine is marked 100 and 
the 
worst 
state you 
can 
imagine is marked 0. 
We would like you to indicate 
on this scale how good or bad 
your own health is today, in 
your opinion. Please do this 
by drawing a line from the box 
below to whichever point on 
the scale indicates how good 
or bad your health state is 
today. 
Your 
own 
health state 
today 

Protocol ESC-16-001
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2.3  Secondary Safety Endpoints: 
The following data will be summarized by treatment group. The continuous variables will be 
summarized descriptively by number of subjects, mean, standard deviation, minimum, and maximum. 
Categorical data will be summarized descriptively by frequencies along with the associated 
percentages. 
1. The incidence of SSI following surgery as defined by:
a.
CDC criteria[11]:
1)
Superficial incisional SSI：
Infection occurs within 30 days after the operation and infection involves only skin or
subcutaneous tissue of the incision and at least one of the following:

Purulent drainage, with or without laboratory confirmation, from the superficial
incision;

Organisms isolated from an aseptically obtained culture of fluid or tissue from the
superficial incision;

At least one of the following signs or symptoms of infection: pain or tenderness,
localized swelling, redness, or heat and superficial incision, is deliberately opened by
surgeon, unless incision is culture-negative;

Diagnosis of superficial incisional SSI by the surgeon or attending physician.
Do not report the following conditions as SSI: 

Stitch abscess (minimal inflammation and discharge confined to the points of suture
penetration); 

Infection of an episiotomy or new born circumcision site;

Infected burn wound;

Incisional SSI that extends into the fascial and muscle layers (see deep incisional
SSI).
Note: Specific criteria are used for identifying infected episiotomy and circumcision sites and 
burn wounds. 
2)
Deep incisional SSI：
Infection occurs within 30 days after the operation if no implant is left in place or within 1 year
if implant is in place and the infection appears to, be related to the operation and infection
involves deep soft tissues (e.g., fascial and muscle layers) of the incision and at least one of
the following:

Purulent drainage from the deep incision but not from the organ/space component of
the surgical site;

A deep incision spontaneously dehisces or is deliberately opened by a surgeon when
the patient has at least one of the following signs or symptoms: fever (>38ºC),
localized pain, or tenderness, unless site is culture-negative;

An abscess or other evidence of infection involving the deep incision is found on
direct examination, during reoperation, or by histopathologic or radiologic
examination;

Diagnosis of a deep incisional SSI by a surgeon or attending physician.
Notes: 

Report infection that involves both superficial and deep incision sites as deep
incisional SSI;

Report an organ/space SSI that drains through the incision as a deep incisional SSI.
3)
Organ/Space SSI:
Infection occurs within 30 days after the operation if no implant is left in place or within 1 year
if implant is in place and the infection appears to, be related to the operation and infection

Protocol ESC-16-001
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involves any part of the anatomy (e.g., organs or spaces), other than the incision, which was 
opened or manipulated during an operation and at least one of the following: 

Purulent drainage from a drain that is placed through a stab wound into the
organ/space; 

Organisms isolated from an aseptically obtained culture of fluid or tissue in the
organ/space; 

An abscess or other evidence of infection involving the organ/space that is found on
direct examination, during reoperation, or by histopathologic or radiologic 
examination; 

Diagnosis of an organ/space SSI by a surgeon or attending physician.
No confirmatory culture will be required unless deemed by the physician per local 
standard of care to provide appropriate treatment to subject. 
b.
ASEPSIS Score (only for patients with confirmed SSI):  assesses severity of wound
infection using numerical scoring (as opposed to the CDC’s absence or presence of SSI
and type). The ASEPSIS Wound Score evaluates would characteristics and additional
treatments as predictors of infection that may develop once the subject leaves the
hospital. These include the presence of serous exudates, erythema, purulent exudates,
separation of deep tissues, antibiotics, drainage of pus, wound debridement, isolation of
bacteria, and requirement for inpatient stay.   Surgeons assess each parameter and
provide a numerical score based upon objective criteria of wound appearance and clinical
consequences of the infection. Extra points were added for antibiotic treatment of SSI (10
points), drainage of pus under local anesthesia (5 points), debridement of the wound
under general anesthesia (10 points), isolation of bacteria from the wound (10 points),
and an inpatient stay of more than 14 days (5 points). An overall score, ranging from 0 to
100, is then calculated to define wound severity according to the proportion of the wound
affected by each of these characteristics[12, 13]. Refer to Table 2:
2. Use Acute Inflammatory Response Evaluation (AIRE) score measuring inflammatory tissue
reaction. Of note, an AE will be reported when the score is >1. Refer to Table 3[14, 15]:
3. Incidence of would separation or dehiscence requiring intervention;
4. Incidence of delayed wound healing events;
5. Incidence of wound closure related adverse events and serious adverse events;

Protocol ESC-16-001
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Table 2:  ASEPSIS Score 
Wound Characteristic 
Proportion of Wound Affected 
0
<20 
20-39 
40-59 
60-79 
>80
Serous Exudate
0
1
2
3
4
5
Erythema
0
1
2
3
4
5
Purulent Exudate
0
2
4
6
8
10
Separation of Deep Issue 
0 
2 
4 
6 
8 
10 
Points are scored for daily wound inspection. 
Additional Treatment 
Points 
Antibiotics
10
Drainage of Pus under local anesthesia 
5 
Debridement of Wound (General Anesthesia) 
10 
Serous Discharge* 
Daily 0-5 
Erythema*
Daily 0-5
Purulent Exudate* 
Daily 0-10 
Separation of Deep Tissues* 
Daily 0-10 
Isolation of Bacteria 
10 
Stay as In-patient  Prolonged Over 14 Days 
5 
*Given scores on 5 of 7 days and the highest weekly score used.
Category of Infection 
Total Score** 
Definition 
0-10
Satisfactory Healing
11-20 
Disturbance of Healing 
21-30
Minor Wound Infection
31-40 
Moderate Wound Infection 
>40
Severe Wound Infection
**Total Score calculated adding scores for individual wound characteristics and additional treatment. 
Table 3: Acute Inflammatory Response Evaluation (AIRE) Score 
Score 
Erythema 
Oedema 
Pain 
Temperature 
0 
None observed 
None observed  
None  
None  
1 
Slight blanching 
redness along 
incision closure line 
Slight increase in 
tissue firmness 
(turgor)  
Pain at site with 
pressure  
Slightly warmer 
compared to 
adjacent skin  
2 
Moderate redness 
extending < 2 mm  
Pitting of skin around 
incision with mild 
pressure  
Pain at site with 
touch  
Definitely warmer 
compared to 
adjacent skin  
3 
Intense redness 
extending > 2 mm  
Tense firmness of 
skin around incision  
Continuous pain  
Radiating heat at 
incision site  

Protocol ESC-16-001
      &21),'(17,$/
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Version/Date: Original/13 SEP 2016 FINAL 

,QYHVWLJDWLRQDO3ODQ
2YHUDOO6WXG\'HVLJQDQG3ODQ'HVFULSWLRQ
This is a multicenter, single blind prospective, randomized controlled study in patients undergoing 
elective TKA and meeting the study’s eligibility criteria. Eligible patients will be randomized on 1:1 
basis to have the surgical incision closed with either STRATAFIX Symmetric PDS Plus or 
conventional sutures. The plan is to randomize at least 92 subjects for eachof the two groups into 
this study in about 8 sites. Wound closure and surgical procedure times will be determined 
perioperative. Patients will remain blinded to the type of sutures utilized for closure of the incision.  
6WXG\3RSXODWLRQ
,QFOXVLRQ&ULWHULD
Subjects satisfying the following criteria will be considered eligible for enrollment in this study: 
1.
Patient is 18 and <80 years of age;
2.
Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;
3.
Patient is willing to participate in the study, comply with study requirements, follow-up
schedule, and give written informed consent; and
4.
Patient agrees not to schedule any additional elective surgical procedures until
participation in this study is complete.
([FOXVLRQ&ULWHULD
Subjects meeting any of the following criteria will not be eligible for enrollment: 
1.
Female patient who is pregnant or lactating at the time of screening;
2.
Patient has a Body Mass Index (BMI) > 40 kg/m2;
3.
Patient is not able to walk independently (inability to walk at least 10 consecutive meters
without a walking aid);
4.
Patient has had a surgical intervention during the past 30 days for treatment of painful
joint or its underlying etiology;
5.
Patient has had previous open surgeries on the affected joint other than arthroscopy;
6.
Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition
that would interfere with wound healing;
7.
Patient is allergic to poly (p-dioxanon), IRGACARE®* MP (triclosan) or D&C Violet No. 2;
8.
Patient has diabetes with fasting plasma glucose (FPG)  10.0 mmol/L;
9.
Patient has a history of immunosuppressive drug use, including steroids, within the last 6
months;
10. Patient has undergone chemotherapy or radiation within the last 6 months prior to study
enrollment or is scheduled to do so during the study period;
11. Patient has known personal or family history of keloid formation or hypertrophy;
12. Patient has other dermatologic conditions known to impair wound healing;
13. Patient is participating in any other investigational drug (within 30 days or 5 half-lives of
an investigational drug) or device study;
14. Patient has any physical or psychological condition which would impair study participation;
and
15. Patient is judged unsuitable for study participation by the investigator for any other reason.
5HPRYDORI6XEMHFWVIURP6WXG\
g
p
r STRATAFIX Symmetric PDS Plus 

Protocol ESC-16-001
      &21),'(17,$/
Page 21 of 35
Version/Date: Original/13 SEP 2016 FINAL 
In accordance with the current revision of the Declaration of Helsinki, a subject has the right to 
withdraw from the study at any time for any reason without prejudice to their future medical care 
by the physician or the institution. Should a subject (or subject’s legally authorized 
guardian/representative) decide to withdraw, 1) all data collected up to the point of withdrawal will 
be considered for analysis; and 2) all efforts will be made to collect and report the final visit 
observations as thoroughly and timely as possible. The primary reason for early withdrawal will 
be recorded in the electronic case report form (eCRF), as such: 
$GYHUVH(YHQW
When the subject experiences an AE and the PI or Medical Monitor believes it is in their best 
interest to discontinue participation in the study, the subject will be withdrawn from the study. 
:LWKGUDZDORIFRQVHQW
Any method of contact with the subject in which they state they no longer want to participate in 
the study specific activities constitutes withdrawal of consent for participation in the study. When 
possible, the reason for withdrawal will be documented. 
6LWH7HUPLQDWLRQRU6WXG\7HUPLQDWLRQ
A study site or the entire study may be terminated. When this occurs, all subjects currently 
enrolled at the site will be withdrawn and documented as early terminations. Reasons for site or 
study termination may include, but are not limited to the following: 
Ь Administrative Concerns (e.g., inadequate subject enrollment, Investigator/institution
non-compliance, change of business strategy, etc.); 
Ь Safety Issues, including those due to non-compliance, which substantially affect the risk to
benefit ratio of the study subjects at a site or for the study as a whole; or 
Ь Regulatory Body Mandate(s).
'HDWK
Ь When possible, the cause of death will be documented.
2WKHU
Ь Either deep or intermediate layer can’t be closed by one STRATAFIX Symmetric PDS Plus
suture; 
Ь PI believed the incision is not suitable to be closed by absorbable suture (e.g., the tissue where
prolonged (beyond six weeks) approximation of tissue under stress is required). 
6WXG\3URFHGXUH

3URFHGXUH'HVFULSWLRQ
TKA Surgical Procedure: 
It is suggested that no more than two surgeons at each would investigative site perform the 
wound closure procedure of TKA to minimize bias and variability. The TKA procedure will be 
performed per each institutional requirements or specific guidelines with a median incision[16-20]. 
The length of incision is recommended to be no longer than 15 cm. 
Wound Closure Procedure: 
The wound closure will be performed at genuflex position.  
For patients randomized to receive barbed sutures, the deep layer and the intermediate layer will 
be repaired and closed by using one STRATAFIX Symmetric PDS Plus suture respectively. The 
p
y
 STRATAFIX Symmetric PDS Plus 
 STRATAFIX Symmetric PDS Plus

Protocol ESC-16-001
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Version/Date: Original/13 SEP 2016 FINAL 
ratio of incision length to suture length for both layers is recommended to be no higher than 1:3. 
For patients randomized to receive conventional sutures, CR8 VICRYL® PLUS sutures will be 
used to close the deep and the intermediate layers with interrupted suturing manner. Then for 
both groups, STRATAFIX Spiral PGA-PCL sutures will be used to close the intradermal layer and 
the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be 
applied to the skin surface to tissue approximation. Please find the details in Table 4,5. 
7DEOH:RXQGFORVXUHSURFHGXUHDQGGHYLFHVLQEDUEHGVXWXUHJURXS 
/D\HU
6XWXUH0DWHULDO
6XWXUH7HFKQLTXH
&RGH
Deep layer 
0 STRATAFIX Symmetric PDS Plus 
Continuous 
SXPP1A406 
Intermediate layer 
2-0 STRATAFIX Symmetric PDS Plus 
Continuous 
SXPP1A403 
Intradermal  layer 
3-0 STRATAFIX Spiral PGA-PCL 
Continuous 
SXMD2B406/ 
SXMD2B408 
Skin layer 
DERMABOND™ Advance™ 
N/A 
ANX12 
7DEOH:RXQGFORVXUHSURFHGXUHDQGGHYLFHVLQFRQWUROJURXS
/D\HU
6XWXUH0DWHULDO
6XWXUH7HFKQLTXH
&RGH
Deep layer 
0 CR8 VICRYL® PLUS 
Interrupted 
VCP752D 
Intermediate layer 
2-0 CR8 VICRYL® PLUS 
Interrupted 
VCP739D 
Intradermal  layer 
3-0 STRATAFIX Spiral PGA-PCL 
Continuous 
SXMD2B406/ 
SXMD2B408 
Skin layer 
DERMABOND™ Advance™ 
N/A 
ANX12 
The sutures and TSA will be used per the Instructions for Use [21-24]. Surgeons must be familiar 
with surgical procedures and techniques involving absorbable sutures as risk of wound 
dehiscence/separation may vary with the site of application and the suture material used. 
Consequently, surgeons must consider the in vivo performance when evaluating the eligibility of 
potential subjects for enrollment into the study. The use of an absorbable suture may be 
inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from 
conditions which may delay wound healing.  
Postoperative Care: 
Postoperative care will be performed per institutional requirements ROM exercises will be 
performed adhering to institutional requirements and specific guidelines regarding postoperative 
care.  Patient status is monitored closely until discharge. Thrombolytic therapy beyond discharge 
can be continued prophylactically per intuitional requirements or not. Changes in concomitant 
medications including analgesics will be recorded throughout inpatient stay. 
Other – Health Economic Data Collection 
In order to estimate the costs characteristics and influence factors, the following costs data will be 
collected if available: 
Overall fee: Total fees, hospital stay fees, self-paid amount, etc 
Comprehensive medical services costs, including general medical service charges, general 
treatment procedure fees, and nursing costs, etc. 
Diagnosis fees, including pathological diagnosis fee, imaging diagnosis fee, clinical diagnosis fee, 
and laboratory diagnosis fee, etc. 
CR8 VICRYL® PLUS 
p
STRATAFIX Spiral PGA-PCL 
g
p ,
 DERMABOND™ Advance™ 
p
0 STRATAFIX Symmetric PDS Plus 
2-0 STRATAFIX Symmetric PDS Plus 
y
3-0 STRATAFIX Spiral PGA-PCL 
y
DERMABOND™ Advance™ 
SXPP1A406 
SXPP1A403
SXMD2B406/ 
SXMD2B408 
ANX12
0 CR8 VICRYL® PLUS
2-0 CR8 VICRYL PLUS
L®
3-0 STRATAFIX Spiral PGA-PCL 
DERMABOND™ Advance™ 
VCP752D 
VCP739D
SXMD2B406/ 
SXMD2B408
ANX12

Protocol ESC-16-001
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Treatment fees, including non-operation treatment fee (clinical physical treatment fee), operation 
costs (anesthetic fee, procedure costs) 
Rehabilitation fee, including rehabilitation costs, etc. 
Medicines fee, including traditional Chinese medicine, western Chinese medicine, antibiotic fees, 
etc.  
Blood and blood products costs, including fees of blood, blood coagulation products, etc. 
Medical supplies costs, including fees of disposal medical supplies for examination, fees of 
disposal medical supplies for treatment, and disposal medical supplies for surgery, etc. 
The other costs, if applicable.  
3.3.2 
Blinding 
Blinding practices for this study will include the following: 
Patients: Patients will be informed of the 1:1 randomization between the different suturing 
material and technique, but will remain blinded as to which implant they actually received until 
after they have completed all study follow-up. 
Implanting surgeon: It is not possible to blind the implanting physician due to the different suturing 
technique and  products. 
Medical Records: All medical records (source documents) documenting the implant procedure 
through hospital discharge and all follow-ups will not be blinded because the devices used will be 
descript in the operation record. 
Monitors: Monitors will not be blinded because the detachable labels provided with the product 
identify the product and may be used in the study device accountability records and patient 
research file for the purpose of device accountability and source document validation. 
3.3.3 
Subject Compliance 
Study personnel will make preemptive contact with subjects as necessary to ensure compliance 
with the follow-up schedule. 
3.4 Study Procedures 
Screening 
Subjects will be consented prior to any actual study-specific screening procedures being 
conducted. Subjects will be considered enrolled into the study upon satisfaction of the following 
criteria: 

Completion of the informed consent process and signing the ICD;

Verification of the eligibility criteria (Sections 3.2) by the PI and authorized investigators.
The verification must be conducted by the PI and/or authorized investigators prior to
randomization.
Screening Failures 
Screened subjects who are not enrolled will be considered screen failures. For subjects 
who are determined to be screen failures, only the following data will be recorded on the 
eCRF: 

Informed consent date;

Protocol ESC-16-001
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Version/Date: Original/13 SEP 2016 FINAL 

Demographic information (age, race, gender, and ethnicity);

Reason for screening failure.
Randomization 
Randomization will occur if the patient meets all inclusion criteria and does not meet any   
exclusion criteria.  
Each case will be randomized to one of two groups in a 1:1 ratio. The only difference between the 
groups will be the suturing material and technique. The plan is to randomize at least 92 subjects 
for each of the two groups. A central randomization will be used in this study so that the study 
team cannot guess the upcoming assigned group. 
3.4.1 
Visit 1 – Screening/Baseline Visit 
The following screening activities will occur prior to the study procedure (performed within 30 
days of surgery): 

The subject must be given ample time to review and sign the ICD;

Collection of demographic information (year of birth, race, gender, ethnicity,  education,
occupation);

Review and collection of medical/surgical history

Review/collection of inclusion/exclusion criteria and determination as to whether the
subject is eligible for participation (retrospective data, per site SOC, is permitted to
determine eligibility);

Urine/blood pregnancy test;

Date of hospital admission;

Knee Pain VAS

EQ-5D-3L

Physical Examination, including height, weight and ROM of knee; and

Concomitant medications (including pain and antibiotics) from the admission;
3.4.2 
Visit 2 – Randomization 
The following must be obtained prior to the surgical procedure: 

Interactive web response system/ interactive voice response system

Confirm inclusion and exclusion criteria

Concomitant medications including pain and antibiotics
3.4.3 
Visit 3 – Surgical Procedure 
3.4.3.1 Pre-procedure  
The following must be obtained prior to the surgical procedure: 

Update to medical/surgical/ history

Concomitant medications including pain and antibiotics

Protocol ESC-16-001
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3.4.3.2 Intraoperative 
Data collected during procedure: 

Procedure time:
-    The time in minutes and seconds by a calibrated stopwatch between placement of the 
first suture throws in the deep tissue to the completion of intradermal layer closure. Total 
operation time: defined as the time in minutes beginning with first incision to skin closure. 

Overall operating room (OR) time： defined as the time in minutes from anesthesia to
exiting the OR; 

Device usage data
- 
The code and quantity of wound closure device, including suture and TSA  

Operating room resource utilization;

Intra-operative device failure rates;

Anesthesia method;

Wound Complication Assessment;

Concomitant medications including pain and antibiotics (except for anesthesia
medications)..; 

Adverse Events (Concomitant medication usage associated with AEs will also be
captured) 
3.4.4 
Visit 4 – Post-Op through Discharge 
The following must be obtained in this visit. 

Knee pain VAS

ROM

EQ-5D-3L

Concomitant medications including pain and antibiotics

Wound Complication Assessment

Adverse Events (Concomitant medication usage associated with AEs will also be
captured) 

SSI

AIRE

Length of stay: defined as time between procedure and discharge.

Health Economic Data Collection
3.4.5 
Visit 5 – 30-42 Days 
Between 30 and 42 days post procedure; the following must be conducted/obtained: 

Knee pain VAS

ROM

EQ-5D-3L

Concomitant medications including pain and antibiotics

Wound Complication Assessment

Protocol ESC-16-001
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
Adverse Events (Concomitant medication usage associated with AEs will also be
captured) 

SSI

AIRE
4.0 
Data Management and Integrity 
4.1 Data Completion and Record Keeping 
4.1.1 
Source Documents 
Source documents are documents on which information regarding subjects is first recorded, 
including printed, optical, or electronic documents.  Investigator subject files or hospital 
records generally are the basis of source document information.  This includes but is not 
limited to, original subject files; hospital/clinic records; original recordings /tracing; digital 
images from automated instruments; radiographs; device accountability records; 
photographic negatives; and records kept at the investigation site, at the laboratories and at 
other departments involved in the clinical investigation. 
Source documents must be retained by the Investigator as part of the subject’s permanent 
medical record. The information in the source documents is used to complete the eCRFs. All 
information captured on the eCRFs should be completely and accurately supported in source 
documentation. Any additional information relevant to the study should be included in the 
source documents. In particular, any deviations from the study protocol or procedures should 
be recorded in the source documents. The Investigator will retain originals of all source 
documents, subject consent forms, and study data. 
4.1.2 
Electronic Data Capture 
An electronic data capture (EDC) system will be utilized by study site personnel to transfer 
study data from source records (medical records and/or source document worksheets) onto 
common eCRFs. This system is a web-based, secure electronic software application 
(Medidata® Rave, 79 Fifth Avenue, 8th Floor, New York, New York, 10003). This system was 
designed and is developed and maintained by Medidata in a manner that is compliant with 
national and international GCP data protection/data privacy and electronic record/electronic 
signature (e.g., 21 CFR Part 11) regulatory requirements. The EDC system will be used to 
facilitate the collection of all study data at the site. Designated site personnel will be 
responsible for entering patient data into the EDC system. All external and Sponsor internal 
users will be trained on the EDC application at a level dependent on their planned function. 
An EDC digital User Manual will be available under the help menu within the Medidata® 
Rave website to assist in the collection and entry of source data into the electronic casebook.   
A 24/7/365 Help Desk Support line (per Medidata web site) staffed by the outsourced vendor 
will also be available to respond to site-monitor questions. 
4.1.3 
Data Collection 
Each EDC eCRF will be completed by the PI or PI’s designee. Every effort should be made to 
respond to all monitoring and/or data management questions on each eCRF as completion of 
the data is required by the protocol. A unique ID number will identify each subject.  The 
subject’s unique ID number will be visible on each eCRF. At no time should the subject name 
appear on the eCRFs.  
All data should be recorded accurately and completely. The Investigator is responsible for 
reviewing and approving each completed eCRF. Assurance of overall review and approval 

Protocol ESC-16-001
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will be documented by the Investigator electronically signing each subject’s electronic 
casebook.   
4.1.4 
Data Correction 
Required data corrections to eCRFs will be prompted via automated electronic edit checks 
and/or queries manually created by Sponsor reviewers. The change(s), individual making the 
change(s), and time the change(s) were made to the eCRFs will be automatically captured in 
the audit trail within Medidata® Rave. 
4.1.5 
Data Privacy 
The collection, use, and disclosure of all personal data, including subject health and medical 
information, are to be maintained in compliance with applicable personal data protection and 
security laws and regulations that govern protected health information and the informed 
consent given by each study subject. When collecting and processing such personal data, 
appropriate measures are to be taken to maintain the confidentiality of patient health and 
medical information and to prevent access by unauthorized persons. 
4.1.6 
Record Retention, Inspection, and Custody 
The PI must maintain all documentation related to the study for at least ten years after site 
closure (per applicable local regulation) and until they receive Sponsor notification.  The PI 
will allow representatives of the Sponsor, the China Food and Drug Administration (CFDA),, 
or other government regulatory agencies to inspect all study records, eCRFs, and 
corresponding portions of the subject’s office and/or hospital medical records at regular 
intervals during the study. These inspections are to verify adherence to the protocol, integrity 
of the data being captured on the eCRFs, and compliance with applicable regulations. 
Subject medical records will be maintained in a confidential manner. Study reports will not 
identify subjects by name.  
If custody of the records is transferred, notice of such a transfer should be given to the 
Sponsor no later than 10 working days after the transfer occurs. 
4.2 Medical Dictionary Coding 
Medical dictionary coding of verbatim AE, Serious Adverse Event (SAE), and concomitant 
prescription medications terms captured on eCRFs will be performed using a coding thesaurus 
algorithm. The Medical Dictionary for Regulatory Activities and World Health Organization Drug 
Dictionary will be used after data entry and query resolution, via auto-encoding and interactive 
coding processes. 
4.3 Data Quality Assurance 
Steps to be taken to assure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate study centers, review of protocol procedures with the Investigator and 
associated personnel prior to the study, and periodic monitoring visits by the Sponsor.  The 
Sponsor will review eCRF’s for accuracy and completeness during on-site monitoring visits and 
after their return to the Sponsor; any discrepancies will be resolved with the Investigator or 
designees, as appropriate.  The data will be entered into the clinical study database and verified for 
accuracy. 

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
0RQLWRULQJ
This study will be monitored by the Sponsor to ensure: 
x
The rights and well-being of the subjects are protected;
x
Reported study data is accurate, complete, and verifiable from source documents; and
x
The conduct of the study is in compliance with the currently approved
protocol/amendment(s), and with applicable local regulatory requirements.
The extent and nature of monitoring will be predetermined and based on considerations such as 
the objective, design, complexity, and endpoints of the study and mutually agreed to by the 
Sponsor and investigators. Monitors will comply with established written standard operating 
procedures as well as procedures (i.e., monitoring plan) specified by the Sponsor for monitoring 
this study.  These monitoring procedures are characterized in the monitoring plan for this study. 

5HJXODWRU\5HTXLUHPHQWV
This study will be conducted in accordance with ICH Harmonized Triparite Guideline for Good 
Clinical Practice (1996), the Declaration of Helsinki (2008), as well as any other applicable local 
regulatory requirements. 
 3URWRFRO'HYLDWLRQV
A deviation (any activity conducted outside the parameters established by the study protocol) can 
be identified from a number of sources. Potential sources include, but are not limited to: a member 
of the Investigator’s staff, a Sponsor representative during monitoring visits, or a member of the 
data management or statistical groups when entering or analyzing data.  Regardless of the source, 
it is crucial to document the deviation.  The PI will report protocol deviations to the IRB as required 
by the IRB procedures. 
 6WDWLVWLFDO0HWKRGV3ODQQHGLQWKH3URWRFRODQG'HWHUPLQDWLRQRI6DPSOH6L]HV

6WDWLVWLFDODQG$QDO\WLFDO3ODQV
The Data Management and Biostatistics groups of Global Surgery Clinical Development will be 
responsible for the analysis of data from this protocol.  A comprehensive and detailed Statistical 
Analysis Plan (SAP) will be finalized prior to database lock and will supplement the statistical 
design and analysis described in this section. 

'HWHUPLQDWLRQRI6DPSOH6L]H
The proposed sample size of 92 patients per arm (184 total) is considered adequate to test the 
hypothesis that STRATAFIX Symmetric PDS Plus can reduce the time for incision closure 
compared to conventional sutures. Based upon a review of the literature, the mean incision 
closure time was assumed to be 16.89 minutes for conventional sutures, being calculated as a 
weighted (based on number of subjects) mean of the means observed in the studies reviewed. 
The studies reported incision closure times ranging between 14.4 to 26.5 minutes [5, 7-10]. It is 
expected that the STRATAFIX Symmetric PDS Plus can reduce the incision closure time by 
25% compared to conventional sutures; therefore, the assumed mean closure time for 
STRATAFIX Symmetric PDS Plus is 12.67 minutes.  The standard deviations observed in the 
reviewed literature range from 3.43 to 8.5 minutes for the conventional sutures; the standard 
deviation for this study was conservatively assumed to be 8 minutes in both groups for several 
p
p
p
(
 STRATAFIX Symmetric PDS Plus 
 16.89 
g g
 STRATAFIX Symmetric PDS Plus 
p
25%
p
STRATAFIX Symmetric PDS Plus 
;
 12.67 
 8 
ESC-

Protocol ESC-16-001
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reasons, such as the lack of data for STRATAFIX Symmetric PDS Plus, and that this patient 
sample may be older and with larger BMI.  The distribution of incision closure time is assumed to 
be normal. 
The statistical hypotheses for the primary endpoint are as follows: 
x
H0: Mean Barbed  Mean conventional suture tested against the alternative hypothesis
x
Ha: Mean Barbed < Mean conventional suture;
Where: 
x
The assumed mean time to incision closure in  conventional group  is 16.89 minutes;
x
The mean time to closure in STRATAFIX Symmetric PDS Plus is 12.67 minutes;
x
The assumed standard deviations in the two groups are both 8.
Based upon these assumptions, a total seventy seven (77) evaluable subjects per arm will 
achieve 90% power to detect a difference of 4.22 minutes (expected mean for STRATAFIX 
Symmetric PDS Plus of 12.67 minutes and the conventional group of 16.89 minutes) with 
estimated group standard deviations of 8, using a one-sided two-sample t-test. The assumed 
one-sided significance level is 0.025. 
If the higher limit of the one-sided 97.5% confidence interval for the difference in the Mean 
STRATAFIX Symmetric PDS Plus time minus the Mean closure time for conventional suture is 
smaller than 0, then it will be concluded that STRATAFIX Symmetric PDS Plus is considered to 
be superior to conventional suture. The sample size is adjusted to 92 per arm to account for a 
16% withdraw rate [25-28]. 

$QDO\VLV6HWV
   There will be three analysis sets defined: 
x
Modified Intent-to-treat set (mITT set) consists of all randomized subjects who had the
surgical incisions closed using the randomized suture 
x
Evaluable [or Per-Protocol (PP)] set consists of all mITT subjects who have no major
protocol violations. 
x
Safety set consists of all subjects who receive surgery.
Major protocol deviations are deviations that have an impact on the primary endpoint, or that 
have an impact on the randomization assignment.  These will be determined prior to database 
lock.  

$QDO\VLVRI3ULPDU\DQG6HFRQGDU\(IILFDF\(QGSRLQWV
For the primary efficacy endpoint, a one-sided 97.5% confidence interval for the difference in 
treatment group means (Mean STRATAFIX Symmetric PDS Plus closure time PLQXV the Mean 
closure time for conventional suture) will be constructed using the t-distribution.  If the higher 
limit of the confidence interval is smaller than 0, then it will be concluded that STRATAFIX 
Symmetric PDS Plus is considered to be superior to conventional suture. 
The primary efficacy endpoint will be analyzed using the mITT and Per-Protocol analysis sets.  
The mITT analysis will be considered primary analysis.  All secondary efficacy endpoints will be 
analyzed using the mITT analysis set. 
All efficacy endpoints (see section 2.1) will be summarized descriptively by treatment group. The 
continuous variables will be summarized descriptively by number of subjects, mean, standard 
r STRATAFIX Symmetric PDS Plus, 
 STRATAFIX Symmetric PDS Plus  12.67 
 16.89 
y
f 4.22 
p
r STRATAFIX
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Symmetric PDS Plus f 12.67 
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f 8, 
g
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,
 STRATAFIX Symmetric PDS Plus 
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Protocol ESC-16-001
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deviation, minimum, and maximum.  Categorical data will be summarized descriptively by 
frequencies along with the associated percentages. No inferential statistics will be generated for 
the secondary efficacy endpoints. 
4.5.5 
Analysis of Secondary Safety Endpoints 
The incidence of adverse events (AEs) will be assessed at the preferred term level using the 
Medical Dictionary for Regulatory Activities (MedDRA) for event categorization. Incidence of AEs 
will also be assessed by 1) onset time (intraoperative or postoperative); 2) by relationship to study 
surgical procedure; 3) by relationship to the; and 4) by severity.  
All safety endpoints (see section 2.2) will be summarized descriptively by treatment group for the 
Safety analysis set using available data.  There will be no missing data imputation for the safety 
analysis.  The continuous variables will be summarized descriptively by number of subjects, mean, 
standard deviation, minimum, and maximum.  Categorical data will be summarized descriptively by 
frequencies along with the associated percentages.  No inferential statistics will be generated for 
the safety endpoints. 
4.6 Statistical/Analytical Issues 
4.6.1 
Handling of Dropouts or Missing Data 
All summaries of efficacy endpoints will be performed only on subjects who are randomized, and 
only observed data will be summarized. There will be no imputation for missing data or imputation 
of data for early terminated subjects. 
4.6.2 
Multicenter Studies 
No adjustment for this multicenter study will be performed. 
5.0 
Risks and Benefits of the Study Device and Clinical Investigation 
The procedure being performed with the study suture and TSA are identical to the procedure 
subjects would receive as part of their standard of care procedure. To date, no risks have been 
reported with the study device beyond standard risks associated with TKA. This study may provide  
benefits on free wound closure device.  
6.0 
Adverse Event  
6.1 Definitions 
 6.1.1    Anticipated Adverse Events 
There are immediate post-operative events that are changes from the baseline condition of the 
Subject, but are expected events resulting from the surgery. If these events occur, they should 
be recorded in the Subject’s medical record and reported forward as AEs to the study sponsor. 
6.1.2    Pre-existing Condition 
A pre-existing condition is one that is present at the start of the study, and is to be reported as 
part of the subject’s medical history. It must be reported as a new Adverse Event if the intensity, 
frequency, or the character of the condition worsens during the study treatment. 
To avoid confusing pre-existing conditions with AEs during data analysis, the study sites must 
make all attempts to provide start dates for all baseline medical conditions. Any pre-existing 
condition that has worsened in intensity, frequency, or the character of the condition should be 
recorded on the AE eCRF as an exacerbation of the pre-existing condition and the start date 
will be recorded as the time when the exacerbation occurred. 

Protocol ESC-16-001
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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. 
6.1.3    Adverse Event 
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study 
device (study suture) or the study procedure (TKA). An untoward medical occurrence includes 
any new, undesirable medical experience or worsening of a pre-existing condition, which occurs 
at any point from the surgery to Final Visit.   
6.1.4    Expected Morbidity/Anticipated Adverse Events 
An expected morbidity/procedural complication is defined as an AE that is known to be common 
or usual in nature, severity, or incidence during TKA in patients with knee osteoarthritis or other 
diseases.   
Postoperative pain and fever is expected and will not be documented as an adverse event 
unless the Investigator considers the pain or fever to exceed that normally anticipated following 
a TKA procedure. 
6.1.5    Serious Adverse Event 
A Serious Adverse Event (SAE) is any AE that: 
led to a death,
led to a serious deterioration in the health of the subject that either resulted in:
- a congenital deformity or abnormality; 
- a life-threatening illness or injury; 
- a permanent impairment of a body structure or a body function; 
- in-patient hospitalization or prolongation of existing hospitalization;  
- medical or surgical intervention to prevent life-threatening illness or injury; or 
permanent 
impairment 
of 
a 
body 
structure 
or 
a 
body 
function. 
Note: 
“Death” should not be reported as an AE. The cause of death should be reported 
as the AE. The only exception is “Sudden Death” when the cause is unknown. 
6.1.6    Adverse Device Effect (ADE) 
An Adverse Device Effect is any untoward and unintended response to a medical device. This 
includes any event arising from insufficiencies or inadequacies in the Instructions for Use or 
the deployment of the device.  It also includes any event that is a result of user error. 
6.1.7    Serious Adverse Device Effect (SADE) 
A serious adverse device effect is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event or that might have led to any of these 
consequences if suitable action had not been taken or intervention had not been made or if 
circumstances had been less opportune. 
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. 

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6HYHULW\RI$GYHUVH(YHQWV
It is the Investigator’s responsibility to assess the severity of an AE.  A change in severity may 
constitute a new reportable AE. 
The following guideline should be used to determine the severity of each adverse event: 
x 0,/':  Awareness of experience, but easily tolerated. No medical intervention required.
x 02'(5$7(: Enough discomfort to interfere with usual activities. Medical intervention
required.
x 6(9(5(: Inability to carry out usual activities.  Medical intervention (including
hospitalization or prolongation of hospitalization) required.
5HODWLRQVKLSRI$GYHUVH(YHQWV
It is the Investigator’s responsibility to assess the relationship of an AE to the study procedure 
(TKA) and study device. 
The following guidelines should be used in determining the relationship of an adverse event to 
the study device, study procedure, or other causality: 
x 1275(/$7(' The event is due to extraneous causes.
x 3266,%/< 5(/$7(' The event is unlikely associated, but cannot be ruled out with
certainty. 
x 352%$%/< 5(/$7(' The event is likely associated, but another cause cannot be
ruled out with certainty. 
x '(),1,7(/<5(/$7(' The event is associated with a high degree of certainty; or
x 81.12:1The event cannot be defined by the categories listed above.
5HSRUWLQJ$GYHUVH(YHQWV
Investigators are required to report all AEs experienced by subjects from the time of enrollment 
(defined as first incision) until the subject completes the study or terminates early. All AEs, 
regardless of their relatedness to the study device, must be reported in the AE eCRF. The 
investigator will evaluate the intensity of the event, severity of the event, and its relatedness to the 
study device or procedure,. Any necessary medical management of the event will be recorded in 
the subject’s medical record/source document. All AEs must be followed until resolution or until they 
become stable but ongoing. 
The sponsor will follow CFDA’s guideline to request sponsor to report the safety events including 
SAE/AE with timeline, which is regulated by law. 
5HSRUWLQJ6HULRXV$GYHUVH(YHQWV
All of the serious adverse event must be reported to the sponsor as well as China Food and Drug 
Administration and local ethics committee by the site immediately (within 24 hours) after the site 
becomes aware of the information by entering the data into the AE eCRF.  
The Sponsor will report any suspected serious adverse events to the regulatory authorities 
(including CFDA), within the required timeframes of five working days for SAEs that are fatal, and 
fifteen working days for all other SAEs. Given the observational nature of this study, the Sponsor 
will not monitor or enforce adherence to CFDA reporting for non-Ethicon products. 

3URGXFW&RPSODLQWV
3URGXFW&RPSODLQWV'HILQLWLRQ
A product complaint is defined as any written, electronic or oral communication that alleges 
-Ethicon 

Protocol ESC-16-001
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deficiencies related to the identity, labeling, quality, durability, reliability, safety, effectiveness, or 
performance of a device (i.e., Barbed suture) after it is release for distribution (policy of Johnson 
and Johnson Medical Device Quality management).  A product complaint may or may not be 
associated with an AE/SAE.   
Product complaints may include, but are not limited to: 
a)
Product contamination;
b)
Defective components;
c)
Poor packaging or product mix-up;
d)
Device malfunction, which is the failure of a device to perform as intended for this
study; 
e)
Labeling concerns
f)
User errors.
5HSRUWLQJ3URGXFW&RPSODLQWV
All product complaints related to the study (barbed suture/TSA/traditional suture) shall be 
documented throughout the clinical investigation.   
Product complaints related to the study (barbed suture/TSA/traditional suture) must be reported to 
the Sponsor in a timely manner and no later than 24 hours after becoming aware of the event. 
The Product Complaint Form must be faxed to China CHU at the following: JJMC-
productcomplaint-Ethicon@its.jnj.com.  One copy of the processed form should be kept on-site with 
the device concerned, and the device should be retained. Ethicon and /or JJMC representatives will 
organize collection of the device for evaluation. 
5HSRUWLQJ3URGXFW&RPSODLQWVIRU1RQ(WKLFRQ'HYLFHV
In compliance with the requirements of local regulations, describing the handling of product 
complaints, the study site must report all product complaints of other (non-Ethicon) marketed 
products/devices used in this study (e.g., knee prosthesis).  
: JJMC-
p
productcomplaint-Ethicon@its.jnj.com. 
Ethicon 
r JJMC 
(WKLFRQ
g
-Ethicon)

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8.
References
1.
Cram P, Lu X, Kates SL, Sing JA, Li Y. and Wolf BR. Total Knee Arthroplasty Volume, Utilization,
and Outcomes Among Medicare Beneficiaries, 1991-2010. AMA. 2012;308(12):1227-1236.
doi:10.1001/2012.jama.11153
2.
AHRQ Measure Summary NQMC-9373. Total knee replacement: percentage of patients
undergoing a total knee replacement with radiographic evidence of arthritis within one year prior
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http://www.qualitymeasures.ahrq.gov/content.aspx?id=47776&search=Arthroplasty%2c+Replace
ment%2c+Knee
3.
Kurtz S, Ong K, Lau E, et al. Projections of primary and revision hip and knee arthroplasty in the
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Gililland JM, Anderson LA, Barney JK, Ross HL, Pelt C.E, Peters Cl. Barbed Versus Standard
Sutures for Closure in Total Knee Arthroplasty: A Multicenter Prospective Randomized Trial The
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Namba RS, Inacio MC, Paxton EW. Risk factors associated with deep surgical site infections
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Borzio RW, Piveci R, Kapadian BH, Jauregui JJ. Maheshwari AV. Barbed sutures in total hip and
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Ting NT, Moric MM, Della Valle CJ, Levine BR. Use of Knotless Suture for Closure of Total Hip
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Smith EL. DiSegna ST, Shukla PY, Matzkin EG.Barbed Versus Traditional Sutures: Closure
Time, Cost, and Wound Related Outcome in Total Joint Arthroplasty. The Journal of Arthroplasty.
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Gililland 
JM, 
Anderson 
LA, 
Sun 
G, 
Ericksoo 
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Perioperative Closure-related Complication Rates and Cost Analysis of Barbed Suture for
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Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical
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http://www.cdc.gov/hicpac/pdf/guidelines/SSI_1999.pdf
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Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for
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Wilson AP, Weavill C, Burridge J, Kelsey MC. The use of the wound scoring method ‘ASEPSIS’
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Singer AJ, et al. Prospective, randomised, controlled trial of tissue adhesive (2-
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Julious, S. A. 2010. Sample Sizes for Clinical Trials. Chapman & Hall/CRC. Boca Raton, FL.
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Chow, S.-C., Shao, J., and Wang, H. 2008. Sample Size Calculations in Clinical Research
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Machin, D., Campbell, M., Fayers, P., and Pinol, A. 1997. Sample Size Tables for Clinical
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Zar, Jerrold H. 1984. Biostatistical Analysis (Second Edition). Prentice-Hall. Englewood Cliffs,
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