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CompletedNCT03285529Updated Nov 19, 2020Results posted

The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty

An interventional study of STRATIFIX and VICRYL in Wound; Knee, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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 is anticipated to be faster and more cost-effective than interrupted suturing.

Read the detailed description

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 Stratfix 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).

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).

02

Conditions studied

  • Wound; Knee

Keywords

  • barbed suture
  • knoteless suture
  • total knee arthroplasty
  • wound
  • closure
  • time
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
  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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    STRATAFIX GROUP

    STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. 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) followed by the use of steri-strips and adhesive

    Device: STRATIFIX

  • Placebo comparator
    CONTROL GROUP

    The arthrotomy (deep layer) is repaired using Vicryl #1 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, following total knee arthroplasty.

    Device: VICRYL

Interventions

  • DeviceSTRATIFIX

    STRATIFIX symmetric PDS Plus; Stratifix knotless suture

  • DeviceVICRYL

    Vicryl #1

05

What researchers measure

Primary outcomes

  1. Time to Close, Minutes

    Time from first needle insertion to complete skin closure per protocol

    Time frame: Day of surgery

Secondary outcomes

  1. Number of Participants With Wound Complications

    superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.

    Time frame: 90 days postoperative

06

Results

Posted Nov 19, 2020

Participant flow

Participant flow — Overall Study
MilestoneSTRATAFIX GROUPCONTROL GROUP
Started3030
Completed3030
Not completed00

Outcome measures

PrimaryTime to Close, Minutes

Time from first needle insertion to complete skin closure per protocol

Time frame:
Day of surgery
Reported as:
Mean · minutes
Time to Close, Minutes
minutesSTRATAFIX GROUPCONTROL GROUP
Time to Close, Minutes19 ± 0.0828 ± 0.13
SecondaryNumber of Participants With Wound Complications

superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.

Time frame:
90 days postoperative
Reported as:
Count of participants · Participants
Number of Participants With Wound Complications
ParticipantsSTRATAFIX GROUPCONTROL GROUP
Number of Participants With Wound Complications33

Adverse events

Collected over 90 days postoperative. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
STRATAFIX GROUP0/30 (0%)0/30 (0%)3/30 (10%)
CONTROL GROUP0/30 (0%)0/30 (0%)3/30 (10%)
Most frequent other events
Most frequent other events
EventSTRATAFIX GROUPCONTROL GROUP
Wound dischargeInfections and infestations0/302/30
Superficial surgical site infectionInfections and infestations1/300/30
Wound dehiscenceInfections and infestations0/301/30
Wound hematomaMusculoskeletal and connective tissue disorders1/300/30
Stitch abscessInfections and infestations1/300/30

Baseline characteristics

total knee arthroplasty patients

Age, Continuous
Age, Continuous(years)STRATAFIX GROUPCONTROL GROUPTotal
Mean68 ± 766 ± 767 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)STRATAFIX GROUPCONTROL GROUPTotal
Female161733
Male141327
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)STRATAFIX GROUPCONTROL GROUPTotal
Count of participants——0
Wound length
Wound length(centimeters)STRATAFIX GROUPCONTROL GROUPTotal
Mean17.1 ± 2.016.1 ± 1.316.6 ± 1.9
07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Publications

  • Sundaram K, Warren JA, Klika A, Piuzzi NS, Mont MA, Krebs V. Barbed sutures reduce arthrotomy closure duration compared to interrupted conventional sutures for total knee arthroplasty: a randomized controlled trial. Musculoskelet Surg. 2021 Dec;105(3):275-281. doi: 10.1007/s12306-020-00654-y. Epub 2020 Mar 7. PubMed 32146687 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 17, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — No data will be shared with other researchers.

09

Registry details

Key details

Study ID
NCT03285529
Lead sponsor
The Cleveland Clinic
Responsible party
Viktor Krebs, M.D. (Vice Chairman - Adult Reconstruction, The Cleveland Clinic) — Principal investigator
First posted
Sep 18, 2017
Start date
Sep 26, 2017
Primary completion
Feb 28, 2019
Completion
May 31, 2019
Results posted
Nov 19, 2020
Last update
Nov 19, 2020

Study contacts

Viktor Krebs, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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