Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
Phase: NA
Conditions: Arthroplasty
Sponsor: NYU Langone Health

 
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Official Title: 
Knotless Suture in Revision Total Joint Arthroplasty: A Prospective 
Randomized Controlled Trial 
NCT Number: 
NCT04403919 
Study Number: 
20-00280 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
 December 8, 2020 
 
 

Study #: 20-00280 
Version: September 14, 2020 
Amendment #1 
 
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Knotless Suture in Revision Total Joint Arthroplasty: A 
Prospective Randomized Controlled Trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator: 
Ran Schwarzkopf, M.D., M.Sc. 
Associate Professor 
Associate Division Chief 
Adult Reconstructive Division 
Director Adult Reconstruction Research Center 
Department of Orthopedic Surgery  
NYU Langone Orthopedic Hospital 
301 East 17th Street, Suite 1402 
New York, NY 10003 
Phone: (646)-501-7300 
Email: Ran.Schwarzkopf@nyulangone.org 
 
 
 
 
 
 
 
 
 
 

Study #: 20-00280 
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1. INTRODUCTION 
1.1. BACKGROUND 
 
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) have evolved into immensely successful 
procedures for the treatment of a variety of knee and hip joint pathologies. However, due to a number of 
indications, including infection, mechanical loosening, instability, polyethylene wear, stiffness, and 
periprosthetic fracture there remains a growing need for revision TKA and revision THA 1–3. Revision total 
joint surgery is a large financial burden to the United States healthcare system with projections assuming 
over a 5-fold increase by 2030 4. Advancements in postoperative care, surgical planning, patient selection 
and surgical technique have improved revision TJA outcomes. However, an often-overlooked variable in 
revision total joints is an effective wound closure. Effective wound closure is essential in the immediate and 
long-term outcomes of post-operative complications, wound healing, operative efficiency, and patient 
satisfaction after primary or revision total joint arthroplasty2–5.  
 
Revision TJA is usually performed through non-naïve tissue planes creating concerns for wound healing 
and tissue vascularity. Incisions are typically larger than primary joint arthroplasties, may take longer to 
close and involve more complex closures 6,7. Decreasing closure time is appealing as not only is it cost 
effective but there is data to support increased operative time increases risk for infection.  
 
Barbed suture has been studied in primary hip and knee arthroplasty with data demonstrating faster closure 
times, cost efficiency, and no increase in glove perforation.7–9 Cadaveric studies indicate barbed suture 
creates a more water tight arthrotomy closure, which can reduce wound drainage10. Prolonged wound 
drainage and hematoma formation increase the risk for surgical site infection and deep wound infection. 11 
Biomechanical studies under cyclic loading barbed suture is equivalent to conventional interrupted closure 
and performed better when intentionally damaged and cycled which clinically may translate to decreased 
wound dehiscence.12 Wound dehiscence is a risk factor for recurrence of infection after two stage 
reimplantation 13 
 
In the setting of revision for infection monofilament and antibacterial sutures are used to decrease bacterial 
adherence and load in the surgical wound. In primary total joint arthroplasty braided antibacterial 
absorbable suture and barbed suture have been shown to be as efficacious, with barbed suture having 
faster closure times and overall cost savings. 14 Monofilament barbed suture has outperformed braided 
suture in contaminated wound models and performed equally well as monofilament suture 15. 
 
Our institution does a large number of revision arthroplasties, closure is determined by surgeon preference, 
with variability amongst surgeons. Retrospective review performed by Levine et al report no notable 
adverse response to barbed suture in primary or revision arthroplasty and no change in complication or 
wound healing rates since adopting barbed suture closure with decreased closure time. 9. To our knowledge 
there has been no prospective randomized studies performed on barbed suture in the revision setting.  
 
1.2. 
RATIONALE 
 
Our study seeks to demonstrate efficacy of barbed suture closure in the revision setting. Use of barbed 
suture has been demonstrated to be safe in primary hip and knee surgery however no one has prospectively 
investigated barbed suture closure in the revision setting (9,14,16–18). Animal and biomechanical studies 
have shown that barbed suture is equivalent to monofilament in revision setting for infection and 
outperforms traditional suture for strength in arthrotomy closure. By comparing traditional closure with 
barbed suture, we can decrease wound closure time, control costs, and number of needles handled by 
operative staff without sacrificing cosmesis.  
 
There have been no prospective randomized trials of barbed vs traditional suture in the revision setting. In 
a single center retrospective review Levine et al found no notable differences in wound healing or 
complications for primary and revision total joints treated with barbed suture closure as compared to their 
historic rates (9).  
 
 

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2. STUDY OBJECTIVES AND HYPOTHESIS 
2.1. PRIMARY STUDY OBJECTIVE 
 
Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data 
suggests barbed suture represents no increased complications in the revision setting. Barbed suture may 
represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies 
comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical 
complexities of closures using closure time without sacrificing cosmesis or wound complications between 
the traditional closure and barbed closure.  
 
2.2. SPECIFIC AIMS 
 
To evaluate the closure time, wound cosmesis, and efficiency of barbed suture closure following revision 
total hip and total knee arthroplasty compared to traditional closure.  
 
Primary Objective 
1. To compare surgical complexity of the closures based on closure time  
Secondary Objectives  
1. To evaluate the cost effectiveness of using bidirectional barbed suture compared with traditional 
sutures in revision knee and hip arthroplasty  
2. To evaluate prevalence of complications (including needle sticks and glove perforations) of using 
barbed suture in revision total joint arthroplasty 
3. To evaluate the cosmetic result of barbed versus traditional suture in revision total joint arthroplasty  
4. To quantify the number of sutures used for each type of closure  
5. To perform cost analysis to determine most cost-effective closure  
 
2.3 ENDPOINTS 
Primary Endpoint 
1. Measure the time needed to properly close the wound with each technique 
 
Secondary Endpoints 
1. Record all complications (including needle sticks and glove perforations) and infections related 
to the wound closure 
2. Calculate the cost difference based on supplies, personnel, and OR time between each 
technique 
3. Gather pictures of wound following closure to evaluate the cosmetic result of barbed versus 
traditional suture in revision total joint arthroplasty using the Patient and Observer Scar 
Assessment Scale (POSAS) 
4. Calculate the number of suture used and length of incision for each technique 
 
 
3. STUDY DESIGN/METHODOLOGY 
3.1. STUDY DESIGN 
 
This is a prospective, randomized, controlled trial, parallel four-arm design, single-center study to compare 
barbed versus traditional suture closure in revision total knee and total hip arthroplasty. 
 
3.2. 
STUDY INTERVENTIONS & RANDOMIZATION 
3.2.1. 
STUDY INTERVENTIONS 
 

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3.2.1.1. Revision Total Knee  
 
For revision total knee arthroplasty all closures will be performed with knee in approximately 45 degrees of 
flexion.  
 
Group #1: 
Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus 
followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at 
surgeon’s discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by 
subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond 
advanced. This is considered routine care at NYU Langone Orthopedic Hospital. There is no established 
protocol for suturing the wound. 
 
Group #2: 
The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, 
intermediate layer will be performed at surgeon’s discretion in thin patients, if performed will entail stratafix 
spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl 
plus suture and Dermabond advance. This is considered routine care at NYU Langone Orthopedic Hospital. 
There is no established protocol for suturing the wound. 
 
3.2.1.2. Revision Total Hip  
 
Group #1: Conventional closure  
1. The capsule will be closed with Vicryl Plus number 1 
2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, 
Ethicon; Johnson &Johnson, Somerville, NJ) 
3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl 
plus) 
4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) 
5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson). 
 
 
Group #2: Barbed suture closure 
1. The capsule will be closed with stratafix symmetric PDS Plus 
2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, 
Ethicon; Johnson &Johnson, Somerville, NJ) 
3. Subdermal layer with running number 2-0 barbed suture (stratafix symmetric PDS CT-2, Ethicon; 
Johnson & Johnson, Somerville, NJ) 
4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 
5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson). 
 
 
 
Table 2.  
 
  
Active Arm  
Control Arm  
Capsule 
SXPP1A445 (24 inch) 
Symmetric PDS PLUS- 
Number 1  
Vicryl Plus Number 1  

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Fascia 
SXPP1A445 (24 inch) 
Symmetric PDS PLUS- 
Number 1  
Vicryl Plus Number 1  
Subdermal 
SXPP1B414  (27 inch) 2-0 
Stratafix Spiral PDS Plus 
Violet 70cm CT-2 
Vicryl Plus 2-0 
Subcuticular  
SXMP1B104 Stratafix spiral 
monocryl plus 3-0 
Monocryl 3-0 
Skin 
Dermabond Advanced  
Dermabond advanced  
 
 
 
 
All the devices used in this study are 510(k) cleared. 
- 
Stratafix Symmetric PDS Plus Knotless Tissue Control Devices 
o 
K182873 
- 
Stratafix Spiral Monocryl Plus Knotless Tissue Control Devices 
o 
K182873 
- 
Monocryl Plus Antibacterial Suture 
o 
K050845 
- 
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorbable Suture 
o 
K181652 
 
The frequency of using barbed versus conventional sutures for revision total joint (knees and hips) 
arthroplasty is approximately 75% conventional and 25% barbed at NYU Langone Health. 
 
3.2.2. RANDOMIZATION 
 
Once Revision TJA candidates are successfully screened, patients meeting eligibility criteria will be 
randomized into either the barbed or conventional closure group. After informed consent is obtained and 
the screening interview is conducted, the principle investigator/sub- investigator or research assistant will 
electronically randomize a patient to a study group (barbed or conventional closure group) using the 
REDCap database (web-based secure database application).The NYU Statistics Department will provide 
the randomization scheme that will be used within the REDCap database to randomly assign patients to 
one of the two treatment groups. Each patient who qualifies for entry into the study will be assigned a unique 
study number in chronological order. 
 
4. STUDY POPULATION 
 
The study population will include patients undergoing revision total joint arthroplasty by surgeons from NYU 
Langone Health. All patients who present for evaluation for revision total joint arthroplasty will be screened 
to determine their study eligibility. Only patients who meet inclusion criteria based on the study screening 
protocol will be eligible for study participation. 
 
 
 
 
4.1. INCLUSION CRITERIA 
 
1. Patients ≥ 18 years of age  

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2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following 
indications second stage of two stage reimplantation for infection, mechanical loosening, instability, 
polyethylene wear, stiffness, or periprosthetic fracture 
 
4.2  EXCLUSION CRITERIA 
 
1. Patient is ≤ 18 years of age 
2. Patient is unable to provide written consent 
3. Patient has active infections in the operative leg/joint 
4. Known Allergy to Suture material  
5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or 
psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound 
healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and 
other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity 
will be allowed as they are frequent comorbidities in our revision joint population 
6. Anterior total hip replacement  
7. Stage 1 of two stage revision for infection 
8. Closure performed by plastic surgeon, including flap coverage 
 
Vulnerable populations will not be enrolled in this study. 
 
5.1 Withdrawal Criteria  
 
1. Failure to attend regularly scheduled follow up appointments  
2. Deviation from closure protocol 
 
 
9. STUDY PROCEDURES/DATA COLLECTION 
a. SCREENING STUDY PROCEDURES 
 
Subjects will be recruited by prescreening participating surgeons’ clinic and surgical schedules. Prior to 
consenting, research personnel will evaluate all patients to determine if subjects meet the inclusion and 
exclusion criteria. Participants will continue the use of all medications deemed necessary by their medical 
doctor during the study period. All patients eligible for enrollment will be asked to sign a consent form prior 
to beginning the study by a study team member (sub-investigator, research coordinator, etc.).  
 
b. INFORMED CONSENT 
 
Written informed consent will be obtained from all subjects before any study related procedures are performed. 
The investigator(s) has both ethical and legal responsibility to ensure that each subject under consideration for 
enrollment is given a full explanation of the study. This process must be documented on a written Informed 
Consent Form (ICF) that has already been reviewed and approved by the same Institutional Review Board 
and/or Independent Ethics Committee (IRB/IEC) responsible for approval of the protocol. Each ICF shall 
include the elements required by Food and Drug Administration (FDA) regulations in 21 (CFR) Part 50 and 
International Committee on Harmonization (ICH) Good Clinical Practice (GCP). 
 
Once the investigator or designated research personnel have fully explained the study and answered all the 
potential questions the participant may have and it is agreed that the participant understands the implications 
of participating, the IRB approved informed consent form should be signed and dated by all applicable parties 
in accordance to the IRB/IEC requirements. Study team should give a copy of the signed consent form to the 
participant and the original should be kept in study subject binder or regulatory binder. Explanation of study 
and the signing of the informed consent must occur prior to the subject’s participation in the trial. 
 
If the patient meets the study entry criteria, the study will be introduced to them by study personnel. A thorough 
explanation of the study will be provided to the patient and sufficient time will be provided for the potential 
subjects to thoroughly read the consent form, ask and have all questions about study participation answered, 

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and make an informed decision to participate. The prospective participants will be encouraged to discuss the 
study and their potential participation in the study with their family members or significant others. The patient 
must be able to read the consent form in order to participate in the study. The patient will either provide a written 
signature to signify their agreement to participate in the study or they will decline study participation. In cases 
in which the patient decides not to participate in the study, they will be provided with the standard of care at the 
institution for their surgical procedure. 
  
During the informed consent process, potential study participants will be informed that they may discontinue 
study participation at any time. If a study participant chooses to withdraw from the study, they will be asked to 
notify the principal investigator or a member of the study staff of their intentions. 
 
Potential study participants also will be told that the principal investigator may choose to withdraw a study 
participant from the study for reasons related to noncompliance with the study protocol or if an event occurs 
that would warrant this decision. In such cases, the principal investigator will provide an explanation for the 
decision and the reason why the decision was made. Specific data forms will be completed to document the 
reasons for study participant withdrawal from the study. 
 
c. PRE-OPERATIVE 
Once revision candidates have been identified and consented, patients will be randomized to traditional vs. 
barbed suture closure via RedCap. Medical records will be reviewed for baseline patient characteristics, 
preoperative patient data and laboratory values (Table 1). Prior to operation, a clinical image of the patients 
existing scar will be obtained for research purposes. 
 
Table 1. Collected Baseline Patient Characteristics 
 
 
 
d. 
PERIOPERATIVE 
STUDY 
PROCEDURAL/DATA COLLECTION 
 
The following data points will be collected from the 
medical records and recorded in RedCap 
 
1. 
Time of closure in seconds 
2. 
Incision length 
3. 
Number of sutures used  
4. 
Any needle sticks or glove perforations  
5. 
Type of dressing used (Aquacel or negative 
pressure dressing) 
 
 
e. 
FOLLOW-UP EVALUATION  
i. 
Post-operative hospital course 
 
All patients will be admitted to the hospital and discharge home or to a rehabilitation facility as deemed 
appropriate by the care management team. All patients will be weight bearing as tolerated unless otherwise 
dictated by the surgeon. Any wound complications or skin irritation documented will be documented in the 
subjects’ medical records as part of standard of care.  
 
ii. FOLLOW-UP EVALUATION  
Patients will be assessed at the two to four standard of care post-operative visits up to six months. As part 
of standard of care, at each visit the patient will be evaluated for any complications including: 
a. superficial: skin irritation, erythema, suture spitting, cellulitis, superficial wound dehiscence, 
seroma, hematoma, prolonged wound drainage, need for oral antibiotics, post operatively 
b. Deep: periprosthetic infection, arthrotomy failure, extensor mechanism failure 
c. Other non-closure associated complications  
Baseline Patient Characteristics 
Age 
Gender 
Body mass index (BMI) 
Zip code 
American Society of Anesthesiologist (ASA) 
Score 
Insurance type  
Preoperative complete blood count (CBC), 
basic metabolic panel (BMP), and hemoglobin 
A1c (HbA1c) 
Presence of diabetes mellitus  
Cigarette smoking status 
E-Cigarette smoking status 
Immunocompromised status 
Charlson Comorbidity Index (CCI) 
Indication for Revision Arthroplasty 
 

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For research purposes only, a clinical image of the scar will be taken and stored in the patients’ medical 
record. Patients will be asked to fill out the patient component of the Patient and Observer Scar Assessment 
Scale (POSAS), surgeons will complete the observer scale. The POSAS is a validated reliable scar 
assessment tool used for the evaluation of linear surgical scars taking into account both surgeons and 
patients’ perceptions. This will occur at one of the standard of care post-op appointments between 2-6 
weeks after surgery. 
  
 
 
 
 
 
 
f. 
SCHEDULE OF ACTIVITIES 
 
Study Interval 
Preoperativ
e 
Peri-
operativ
e 
Post-Operative 
Screening 
Date 
of 
Surgery 
Follow-up Visits up 
to 3 months (0-90 
days) 
Review 
of 
demographics 
and 
preoperative 
variables (Table 
1) 
X 
 
 
Measurement 
of 
height, 
weight and BMI 
X 
 
 
Screening—
using eligibility 
criteria 
X 
 
 
Patient Consent 
X 
 
 
Preoperative 
image of scar  
X 
 
 
Perioperative 
Values 
(Table 
2) 
 
X 
 
Postoperative 
Variables 
(Table 2) 
 
X 
X 
 
 
Table 2. Collected peri- and post-operative variables 
Perioperative Variables 

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Closure Time  
Incision Length  
Number of sutures used will be counted and 
recorded  
Any needle sticks or glove perforations  
Dressing Type  
Preoperative Incision Clinical Image 
Postoperative Variables 
Superficial 
wound 
complications: 
Skin 
irritation, erythema, suture spitting, cellulitis, 
superficial 
wound dehiscence, seroma, 
hematoma, prolonged wound drainage 
Deep wound complications: periprosthetic 
infection, 
arthrotomy 
failure, 
extensor 
mechanism failure 
Other non-closure associated complications 
Revision procedures for infection  
Revision procedures for any reason 
Post-operative antibiotic therapy 
Use of chronic antibiotic suppression therapy  
Post-operative Clinical Image (research 
only) 
POSAS Wound Score (research only) 
 
 
10. STUDY DURATION 
 
This study is designed as a prospective longitudinal study with participants remaining in the study for 3 months 
following revision total joint arthroplasty. Data collection for each individual study participant will be concluded 
at the 90-day post- surgical follow-up visit. Duration of the trial is expected to be two years in order to enroll an 
adequate number of patients and follow outcomes for at least 3 months postoperatively. The entire study is 
expected to last approximately 24 months. 
 
11. DATA MANAGEMENT 
 
Data will be collected and managed using REDCap. REDCap (Research Electronic Data Capture) is a secure, 
web-based application designed to support data capture. Monthly performance reports will summarize: patients 
recruited, patients successfully randomized, and the extent of follow-up for the enrolled patients. The reports 
also will evaluate the completeness of collected study data. 
 
Data Collection 
After the patient has enrolled in this study, data will be directly collected from the patient and supplemented 
with electronic medical record (EMR) chart review. Additional data may be extracted from clinical notes. All 
members of the team will be trained in the reproducibly collection of clinical data. All data will then be input into 
REDcap. A member of the research team will be present at each patient follow-up to ensure that all necessary 
data points are collected. In addition, the research team may assist the physician when measuring the patient’s 
functional outcomes.  
 
 
Reporting Requirements 
 
REDCap Features 
 
• HIPAA-compliant and secure. Data are stored on a NYU server behind firewall. 
 
• Intuitive, web-based interface for database build, data entry, and reporting 
 
• Data validation, audit trail, branching logic, and calculated fields 

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• Data dictionary for easy project edits and duplication 
 
• Automated data export (.csv, SPSS, SAS, Stata, R) 
 
• Data import from external sources 
 
12. STATISTICAL ANALYSIS 
 
Power Analysis  
In our analysis if we assume an average length of closure of 30 minutes for revision with standard deviation of 
5 minutes in closure time. The study is powered to compare hip and knee revisions separately. With an 
anticipated average decrease in closure time by five minutes, a minimum of 17 patients need to be included in 
each group (34 revision hips and 34 revision knees) will need be enrolled (power of 80% [alpha=0.025], one-
sided). If we estimate a lost to follow up rate of 15% our recruitment goal will be set at 40 revision knees and 
40 revision hips for a total of 80 revision total joints.  
 
To perform our cost analysis, we assume a mean savings of $200 with a standard deviation of $50 (14). A 
minimum of 3 subjects per treatment group will need to be enrolled (power of 80% [one-sided alpha=0.025]). 
If we estimate a lost to follow up rate of 15%, we will have more than sufficient power with our recruitment goal 
at 80 enrolled patients, 40 revision TKA and 40 revision THA.  
 
Statistical Analysis  
Descriptive statistics will be used to report baseline characteristics as well as primary and secondary outcomes 
for the barbed suture and conventional cohorts. Outcomes will be compared between barbed suture and 
conventional closure (control) for the aforementioned baseline, perioperative and postoperative variables. 
Continuous or ordinal variables will be reported using unpaired t-tests, and all other categorical variables will 
be analyzed using Fisher’s Exact Test. The test for primary endpoint will be one-sided (with the alternative 
hypothesis “mean closure time for barbed suture minus mean closure time for traditional suture <0”) with a 
significance level of 0.025. Two-sided tests will be performed for baseline characteristics of patients and 
secondary endpoints with a significance level of 0.05. To further control for surgeon and evaluator variability 
we will also perform multivariable linear regression for continuous outcomes of interest and logistic regression 
for the dichotomous outcomes. Pooled and subgroup analysis for hip and knee revisions will be performed 
 
 
13. PRIVACY AND CONFIDENTIALITY 
 
Participant Confidentiality 
 
 
• Any information that could identify study participants (i.e. names or medical record numbers) will not 
be included on RedCap. Instead, each study participant will be given a study number. Only the IRB approved 
study staff will be able to link the study numbers to the names of study participants. 
 
• Data collected during the study will be stored electronically in REDCap, a cloud based electronic data 
management system that is password protected. Only IRB approved personnel on the study team will have 
access to this data. 
 
• The names, medical record numbers, or any other unique identifiers of study participants will not be 
included in any publications resulting from this study.  
 
• Research records will be stored in a research study file on an MCIT issued network drive separate 
from the study participants’ medical records. 
 
 
a. RISK AND BENEFITS 
Benefits 
 
There may be no direct benefit to subjects from participating in this study. However, it is hoped that the 
information gained from the study will be of benefit to others in the future.  
  
Risks 
 

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Barbed Suture Closure  
Barbed closure has the potential risks of wound dehiscence, local adverse tissue reaction, extensor mechanism 
failure, delayed wound healing.  
 
Conventional method  
Standard closure has been associated with longer closure time, suture spitting, local irritation reaction, suture 
knot burden 
 
All suture closure has the risk of wound dehiscence, delayed wound healing, adverse tissue reaction, infection 
(superficial or deep) and needle sticks.  
 
Loss of Confidentiality: There is a potential risk of loss of confidentiality. Every effort will be made to protect 
subjects’ confidential information but this cannot be guaranteed. To minimize this risk, all study 
documentation will be stored in a password-protected HIPAA compliant computer with access granted only 
to specific study research personnel. 
 
Unknown Risks: The research may involve risks that are currently unforeseeable. One of these approaches 
may be better than the other. 
 
 
14. ADVERSE EVENTS/REACTIONS 
 
 
Adverse event means any untoward medical occurrence associated with the use of the suture material 
in humans, whether or not considered suture related 
 
 
Adverse reaction means any adverse event caused by any suture material in the study. 
 
 
Suspected adverse reaction means any adverse event for which there is a reasonable possibility that 
the suture material used caused the adverse event. Suspected adverse reaction implies a lesser degree of 
certainty about causality than “adverse reaction” 
 
 
Reasonable possibility. For the purpose of safety reporting, “reasonable possibility” means there is 
evidence to suggest a causal relationship between the suture material used and the adverse event. 
 
 
Life-threatening, suspected adverse reaction. A suspected adverse reaction is considered “life-
threatening” if, in the view of either the Investigator (i.e., the study site principal investigator), its occurrence 
places the patient or research subject at immediate risk of death. It does not include a suspected adverse 
reaction that had it occurred in a more severe form, might have caused death. 
 
 
Serious, suspected adverse reaction. A suspected adverse reaction is considered “serious” if, in the 
view of the Investigator (i.e., the study site principal investigator), it results in any of the following outcomes: 
death, a life- threatening adverse reaction, inpatient hospitalization or prolongation of existing hospitalization, 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a 
congenital anomaly/birth defect. 
 
 
Unexpected, suspected adverse reaction. A suspected adverse reaction is considered “unexpected” if 
it is not listed in the general investigational plan, clinical protocol, or elsewhere; or is not listed at the specificity 
or severity that has been previously observed and/or specified. 
 
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are met: 
 
 
• The test finding is accompanied by clinical symptoms 
 
• The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy. 
 

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Note: simply repeating a test finding, in the absence of any of the other listed criteria, does not constitute an 
adverse event. 
  
 
15. DATA SAFETY MONITORING 
 
No data safety monitoring board will be created for this study. The PI is responsible for data safety monitoring 
of the study. The PI will review all subject safety data, specifically serious adverse events, adverse events 
related to bleeding and wound drainage, and infection on a quarterly basis. The predefined endpoints in any of 
the 4 treatment groups that would result in suspending the study are: 5 or more infections that required re-
revision or wound drainage in over 50% of subjects.   
 
16. Subject Costs and Payments 
 
Subjects will not incur any additional costs associated with this research study. All visits and procedures are 
part of standard clinical care. The sutures used are within the standards of care. Patients and/or their insurance 
will be responsible for their total joint replacement surgery.  
 
Patients will not be compensated for their participation in this study. This study uses standard of care visits and 
we expect most patients to comply with the visit schedule.  
 
Ethicon will provide the suture used in the study at no cost to the patient or institution.  
 
17. ETHICS/CONFLICT OF INTEREST 
 
 
The clinical research study will be conducted in accordance with the current IRB-approved clinical 
protocol; International Conference of Harmonization (ICH) Good Clinical Practice (GCP) Guidelines adopted 
by the FDA; and relevant policies, requirements, and regulations of the New York University IRB, State of New 
York, and applicable federal agencies. 
 
 
None of the principal investigators, co-investigators or study team members should perform, for any 
personal gain, services to any supplier of goods or services, as employee, consultant, or in any other capacity 
which promises compensation of any kind, unless the fact of such transaction or contracts are disclosed in 
good faith, and the board or committee authorizes such a transaction. Similar association by a family member 
of principal investigators, co- investigators or study team members or by any other close relative may be 
inappropriate. 
 
 
This study is undertaken in good faith with Ethicon research support, the company (Ethicon Inc) will 
provide suture and research support for the completion of this study.  
 
18. PUBLICATION & PRESENTATION PLAN 
 
The dissemination of clinical data will include the timely presentation of results at the following scientific 
congresses and orthopedic society meetings: 
 
• 
American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting, Dallas, Texas 
• 
American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting 
 
In addition, the primary investigators and co-investigators will submit a full-length manuscript summarizing the 
results of the study to a peer reviewed medical and/or specialty journal in orthopedic surgery. Sub-analyses of 
other variables and the impact on the primary outcome measures will be published as deemed scientifically 
appropriate. 
  
 
 

Study #: 20-00280 
Version: September 14, 2020 
Amendment #1 
 
Page 13 of 13 
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