The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty
Phase: NA
Conditions: Wound; Knee
Sponsor: The Cleveland Clinic

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Study Protocol Title: Prospective randomized trial of Stratafix vs. Vicryl on operating room 
time and wound closure time in Total Knee Arthroplasty 
 
Protocol Version: 1.0 
Protocol Date: 11/17/2017 
Principal Investigator: Dr. Viktor Krebs, Phone#: 216-445-3834, Email: krebsv@ccf.org 
Funding Sponsor: Johnson and Johnson, Somerville, New Jersey 
Project Contact:   
Christine Romanowski, MD, CCRA  
Sr. Clinical Project Manager  
Clinical Development  
ETHICON, Inc. a Johnson & Johnson Company  
P: 908-218-3156   F: 908-218-5490 Email: cromanow@its.jnj.com  
 
Regulatory Sponsor: 
This study is an Investigator Initiated research trial. Each study site will be considered its own 
regulatory sponsor and is responsible for internal data monitoring and any study reporting 
required by ClinicalTrials.gov. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction: 
Total knee arthroplasty is an effective orthopedic procedure to improve function, correct 
gait, and alleviate symptoms of late-stage arthritis in patients who have failed non-operative 
management.  With constant introduction of various techniques for wound closure, assessment of 
closure times and outcomes will be a topic of marked importance.  
The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless 
Tissue Control suture device is a barbed suture that uses anchor technology to securely engage 
with the soft tissues while also eliminating the need for knots.  The anchors, or barbs, are pressed 
out of the device core or formed within the core in a geometric pattern and arranged in a tapered 
manner to allow the device to pass through tissue in the direction toward the needle during 
closure.  These knotless tissue control devices are deployed using a continuous technique, which 
we anticipate to be faster and more cost-effective than interrupted suturing. 
 
Background and Significance/Preliminary Studies: 
Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and 
deep tissue closures.[1], [2] In addition, barbed sutures have been shown to provide water-tight 
closure and wound strength comparable to or superior to closure with conventional sutures. 
Many comparative studies have been published contrasting barbed sutures to conventional 
closure techniques in multiple surgical fields. [3], [4] 
Various studies have evaluated the outcomes of different barbed suture devices, however 
there are no reports assessing the length of closure times using STRATAFIX (Ethicon, Johnson 
and Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during deep closure in 
total hip arthroplasty. Stephens et al. [5] performed a prospective randomized study of 500 total 
knee arthroplasty patients who received either barbed suture (250) or conventional sutures (250) 
for deep closure of the surgical wound. The mean operating time was significantly shorter in the 
barbed group as compared to conventional group (64.3 vs 68.1 minutes, p=<0.001). In a study of 
80 TKA (61 barbed, 19 conventional deep sutures) and 54 THA patients (37 barbed, 17 
conventional deep sutures), Smith et al. [6] found significantly shorter closure time in the barbed 
suture group (16.78 vs. 26.5 minutes, p<0.001). One study reports one the use of Stratafix suture 
for intracorporeal suturing in myomectomy. Giampaolino et al. [7] performed a prospective 
randomized study on 47 patients and evaluated the mean operative time for laparoscopic 
posterior myomectomy using Stratafix or conventional suture for intracorporeal suturing. There 
was a significant decrease in mean operative time associated with use of Stratafix suture as 
compared to conventional suture (66.3 vs 73 minutes, p=0.005). 

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This prospective randomized single-center study will examine the outcomes, mainly 
closure time, of deep closure during total knee arthroplasty using the STRATAFIX Symmetric 
PDS Plus (Ethicon, Johnson and Johnson, Somerville, New Jersey) barbed suture compared to 
interrupted VICRYL suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).   
 
Regulatory Sponsor: 
This study is an Investigator Initiated research trial. Each study site will be considered its own 
regulatory sponsor and is responsible for internal data monitoring and any study reporting 
required by ClinicalTrials.gov. 

Version 1.1 11/17/17 
 
 
Study Design: 
In this prospective study examining the deep closure during total knee arthroplasty, active 
subjects will receive the STRATAFIX Symmetric PDS Plus (Ethicon, Johnson and Johnson, 
Somerville, New Jersey) suture while the control subjects will receive interrupted VICRYL 
suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).  Superficial closure will be the 
standard of care for both groups.   
The purpose of this study is to compare end points (see below): 
 The primary endpoint of the study will be closure time and operative time.   
 Secondary endpoints will examine: wound complications, costs comparison between the 
two techniques. 
Post-operatively, patients will be assessed at clinic visits at 6 weeks and 3 months.  At these time 
points, we will assess (Table 1):  
Table 1.  
REQUIRED STUDIES 
Pre-Op 
Intra-
operative 
6 week post-op 
3 month post-op 
Informed Consent 
x 
 
 
 
Length of surgery time 
 
x 
 
 
Length of closure time 
 
x 
 
 
Amount of suture material used 
 
x 
 
 
Surgeon experience level  
 
x 
 
 
Wound complications 
 
 
x 
x 
 
Methods 
 A prospective randomized pilot study 
Sample 
 60 subjects for a pilot study 
Inclusion Criteria:  
1. Males and females, between the ages of 18 to 80 years at the time of signing the informed 
consent document. 
2. Understand and voluntarily sign an informed consent document prior to any study-related 
assessments/procedures are conducted. 
3. Able to adhere to the study visit schedule and other protocol requirements. 

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4. Able to fluently speak and understand the local language 
5. If female, is non-pregnant (negative pregnancy test results at the baseline/randomization 
visit) and non-lactating. 
6. End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty 
7. BMI less than 40 kg/m2 
Exclusion Criteria: 
1. BMI greater than or equal to 40 kg/m2. 
2. History of known bleeding disorder.  
3. History of medical co-morbidity that may result in poor wound healing (i.e. diabetes 
mellitus, peripheral vascular disease). 
4. Patients <18 or >80 years of age.  
5. Patients who are prisoners.  
6. Mentally unable to sign informed consent. 
7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the 
patient to be withdrawn from the trial or would otherwise interfere with interpreting the 
results of the study. 
 
Screening and Recruitment: Informed Consent 
 
Informed consent will be obtained by one of the study coordinators/co-investigators 
during a clinical visit prior to procedure in the privacy of an examination room or an office.  
Patients will be informed about the study and inquired about their interest to participate. A 
consent document will be given and key parts of the research study will be explained in lay-
terms to the patient to ensure full understanding.  Any questions regarding the research study will 
be answered at that time.  It will be emphasized that participation is voluntary.  Those patients 
who are willing to participate will be asked to sign the consent document along with the 
consenting researcher.  A signed copy of the consent document will be handed to the patient 
while another copy is kept in their study file.   
 
In the event that an approach prior to the day of surgery is not feasible, same day of 
procedure consenting will be attempted. Patients will be contacted by telephone (see phone 
script), and those interested in participating in the study will be informed about what is involved, 
the follow-up visit, and that participation in the study is strictly voluntary, and will not affect the 
scheduling of their upcoming surgery. If the patient is interested in participating, the patient can 
be either mailed or emailed a copy of the informed consent form, and then arrangements will be 

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made to complete the informed consent process prior to the patient being taken back into the 
preoperative area on the day of surgery. The patient will be asked to come to the hospital on the 
day of surgery earlier than the time they were told to arrive by surgical scheduling in order to 
make sure there will be adequate time to discuss the study, including what is involved, risks, 
benefits, and alternatives. We do not believe that an eventual approach on the same day of 
procedure would represent an added stress for the patient or delay the start of the procedure.  
Similar to obtaining informed consent prior to the day of procedure, the process will occur in a 
private setting with ample time to discuss the study’s implications, risks, benefits, and 
alternatives. No procedures or tests will be conducted on the screening visit after consenting the 
patient. 
 
Randomization procedures: 
Patients will be randomized to either arm of the study as follows: sealed envelopes in a random 
order will be used to place study participants in either the barbed suture arm or in the traditional 
suture arm of the study. Patients will be randomized in a one to one ratio. At the commencement 
of each arthroplasty, a random envelope will be drawn which dictated the type of suture to be 
used, thus blinding the patients to the type of suture they received. 
 
 
Research Procedure:  
A medial parapatellar approach will be performed. All closures will be performed in 3 
layers, with the knee in approximately 90° of flexion to minimize potential imbrication of the 
capsule. For the traditional closure (control group), the arthrotomy (deep layer) is repaired using 
number 1 Vicryl followed by closure of the intermediate layer with a 2-0 Vicryl and a 
subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive.  
For the active arm of the study, wound closure will be performed similarly in 3 layers 
with the use of barbed equivalents at every layer: STRATAFIX symmetric PDS Plus #1 will be 
used to close the capsule (See Table 2).  The subcutaneous layer will be then closed with simple 
interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of 
the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted 
interrupted knots (Monocryl, Ethicon; Johnson & Johnson) followed by the use of steri-strips and 
adhesive (See table 2).  
Closure with the bidirectional barbed suture involves starting at the midpoint of the 
wound and proceeded simultaneously both proximally and distally to the ends. At the ends of the 
wounds, the suture is backstitched at this subcuticular level (2-3 throws) toward the midpoint for 

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further reinforcement before bringing the needle out through the skin; the suture is then cut flush 
with the skin tissue at its free end. With each throw, the leading end of the suture is pulled with 
only enough tension to engage the barbs with the surrounding tissue, thereby locking the wound 
edges into approximation. As with the traditional closure and in concordance with our routine 
protocol, barbed closures were finished with skin steri-strips and adhesive. 
 
Table 2: Suture Type for Closure Following Total Knee Arthroplasty. 
Layer 
Control Group 
Active Group 
Capsule 
Vicryl #1 (J947H#1) 
STRATAFIX (SXPP1A04#1) 
Subcutaneous 
Vicryl 2-0 (J945H 2-0) 
Vicryl 2-0 (J945H 2-0) 
Subcuticular 
Monocryl 4-0 (Y496H) 
Monocryl 4-0 (Y496H) 
Skin 
Steri-strips, glue (Standard of care) Steri-strips, glue (Standard of care) 
 
 
 
Patient Protection: 
 
All data collection sheets will be de-identified. All patients will be assigned a study ID. 
All data collected will be entered into Excel sheet and stored on Cleveland Clinic secure 
computers. Only members of the study team (listed on the IRB application) will have access to 
protected health information of patients included in this study.  
 
Safety Monitoring Plan 
Procedural safety will be documented in this study through patient and surgeon reported 
adverse events. AEs will be documented for all cases in this study. An Unanticipated Problem 
involving risks to participants or others is any event that (1) is unforeseen, (2) caused harm or 
placed a person at increased risk of harm, and (3) is related to the research procedures. 
An Adverse Event (AE) is any untoward or unfavorable medical occurrence, including 
any abnormal sign (for example, abnormal physical exam or laboratory finding), symptoms, or 
disease. Adverse events can encompass both physical and psychological harms. An Internal 
Adverse Event (AE) is an untoward medical occurrence, which occurs to participants in research 
conducted by Cleveland Clinic and/or Cleveland Clinic is the IRB of record. External Adverse 
Event (AE) is an untoward medical occurrence experienced by subjects enrolled at other 

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institutions for the same study approved at Cleveland Clinic or a different study using the same 
study drug/device. A Serious Adverse Event (SAE) is any adverse experience that results in any 
of the following outcomes: 
 Death 
 A life-threatening experience 
 Inpatient hospitalization or prolongation of existing hospitalization 
 A persistent or significant disability/incapacity. 
 A congenital anomaly/birth defect 
 Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered a serious adverse drug experience 
when, based upon appropriate medical judgment, they may jeopardize the patient 
or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
An Unexpected Adverse Event means any AE not previously known or included in the 
current Investigator’s Brochure, consent form or other risk information. 
Related/Possibly Related means there must be reasonable evidence to suggest the event was 
caused by the drug, device or investigational intervention. 
1. Internal Serious Adverse Events (events that occur to participants enrolled in research 
being conducted by Cleveland Clinic or when Cleveland Clinic is the IRB of record) must be 
promptly reported to the IRB using the IRB AE Report Form within10 working days from 
discovery/awareness which meet any of the following criteria as assessed by the PI/Co-I: 
a) Serious, Unexpected and Related/Possibly Related. 
b) AE’s determined to be occurring at a significantly higher frequency or severity than 
expected. 
 c) Other Unexpected AE’s, regardless of severity, that changes the risk benefit ratio of the 
study and results in changes to the Research Protocol or Informed Consent 
process/document. 
            All Internal SAEs are also reported at continuing review using the AE Summary Log. 
 2. External Serious Adverse Events (events experienced by subjects enrolled at other 
institutions for the same study approved at Cleveland Clinic or a different study using the same 
study device/drug) are reportable to the IRB using the IRB AE Report Form within 10 working 
days from discovery/awareness when: 
a. The External SAE report includes reasonable evidence as assessed by a central 
monitoring   entity [Coordinating or Statistical Center, or a Data Safety 

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Monitoring Board (DSMB) or Data Monitoring Committee (DMC)] that the event 
is Serious, Unexpected, and Related/Possibly Related AND places the subjects or 
others at a greater risk of physical or psychological harm than was previously 
known or recognized. This will require a change in the protocol and/or consent 
document. 
 b. External SAE reports provided by the Sponsor to the investigator indicating the 
event is Serious, Unexpected and Related/Possibly related but without reasonable 
evidence or DSMB/DMC determination of greater risk are not reportable to the 
IRB within the 10 day window. Without Sponsor evidence or assessment the 
implications of the event cannot be determined by the research team and therefore 
need not be reviewed. These SAE’ shall be placed on the AE Summary log to be 
submitted at the annual continuing renewal. 
3. DEATHS are to be reported to the IRB using the IRB AE Report Form according to the 
following guidelines: 
a) Internal Death: 
 Related/possibly related whether expected or unexpected– within 5 working days 
from discovery/awareness 
 Not related and expected – at time of continuing review 
 Not related and unexpected – at time of continuing review except cancer studies. 
 Cancer: Not related and unexpected within 10 working days from 
discovery/awareness 
b) External Death: 
Related/possibly related and unexpected – within 5 working days from 
discovery/awareness not related whether expected or unexpected – at time of 
continuing review related/possibly related and expected – at time of continuing 
review 
c) ALL Deaths are also reported at time of continuing review using the AE summary log. 
4. Non-serious Adverse events (Internal and External) that are both Related/Possibly related 
and unexpected are reported on the AE Summary Log at time of continuing review to assess 
trends. 
5. An IRB staff (a qualified, licensed practitioner assigned to this function by the IRB chair 
and IRB Executive Director) reviews Adverse Event Reports to determine whether they 
represent Unanticipated Problem Involving Risks to Participants or Others. Events that are 
assessed, by either the IRB Staff or Investigator, to place subjects or others at a greater risk of 

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harm than was previously known or recognized, or changes the risk/benefit ratio of the study, or 
requires a change in the protocol and/or consent document are referred to Full Board for review 
under Policy #70. Events that do not involve risk to Participants or Others or changes to the 
informed consent or protocol do not require further review. Investigators are informed of the 
determination and the IRB file is updated. 
6. The AE Summary Log is reviewed by the IRB at the time of continuing review to 
identify trends in frequency and severity which may impact subject safety. 
This study is an Investigator Initiated research trial. Each study site will be considered its 
own regulatory sponsor and is responsible for internal data monitoring and any study reporting 
required by ClinicalTrials.gov. 
 
Data Analysis: 
Unless otherwise indicated, all testing of statistical significance will be two-sided, and a 
difference resulting in a p-value of less than or equal to 0.05 will be considered statistically 
significant. Also, after each analysis, General Linear Models (GLM) will be used to control for 
possible confounders, including BMI, gender, age and ethnicity. 
 
References: 
[1] 
A. Sull, S. Inceoglu, A. August, S. Gregorius, and M. D. Wongworawat, “Comparison of 
Barbed Sutures in Porcine Flexor Tenorrhaphy,” HAND, vol. 11, no. 4, pp. 475–478, Dec. 
2016. 
[2] 
P. J. Regier, D. D. Smeak, and K. C. McGilvray, “Security and biomechanical strength of 
three end-pass configurations for the terminal end of intradermal closures performed with 
unidirectional barbed suture material in dogs,” Am. J. Vet. Res., vol. 77, no. 12, pp. 1392–
1400, Dec. 2016. 
[3] 
P. M. Parikh, S. P. Davison, and J. P. Higgins, “Barbed Suture Tenorrhaphy: An Ex Vivo 
Biomechanical Analysis,” Plast. Reconstr. Surg., vol. 124, no. 5, pp. 1551–1558, Nov. 
2009. 
[4] 
A. M. Trocchia, H. N. Aho, and G. Sobol, “A Re-Exploration of the Use of Barbed 
Sutures in Flexor Tendon Repairs,” Orthopedics, vol. 32, no. 10, pp. 731–735, Oct. 2009. 
[5]  
Stephens S, Politi J, Taylor BC. Evaluation of Primary Total Knee Arthroplasty Incision 
Closure with the Use of Continuous Bidirectional Barbed Suture. Surg Technol Int. 2011 
Dec;21:199–203.  
[6]  
Smith EL, DiSegna ST, Shukla PY, Matzkin EG. Barbed versus traditional sutures: 

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closure time, cost, and wound related outcomes in total joint arthroplasty. J Arthroplasty. 
2014 Feb;29(2):283–7.  
[7]  
Giampaolino P, De Rosa N, Tommaselli GA, Santangelo F, Nappi C, Sansone A, et al. 
Comparison of bidirectional barbed suture Stratafix and conventional suture with  
intracorporeal 
knots 
in 
laparoscopic 
myomectomy 
by 
office 
transvaginal 
hydrolaparoscopic follow-up: a preliminary report. Eur J Obstet Gynecol Reprod Biol. 
2015 Dec;195:146–50.