N/A
N=60
The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty
Wound; Knee
Bottom Line
View on ClinicalTrials.gov: NCT03285529 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Time to Close, Minutes — 19; 28 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STRATIFIX (Device); VICRYL (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Close, Minutes |
19; 28 | — |
| SECONDARY Number of Participants With Wound Complications |
3; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Able to fluently speak and understand the local language
- If female, is non-pregnant (negative pregnancy test results at the baseline/randomization visit) and non-lactating.
- End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty
- BMI less than 40 kg/m2
Exclusion Criteria
- BMI greater than or equal to 40 kg/m2.
- History of known bleeding disorder.
- History of medical co-morbidity that may result in poor wound healing (i.e. diabetes mellitus, peripheral vascular disease).
- Patients 80 years of age.
- Patients who are prisoners.
- Mentally unable to sign informed consent.
- Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Data sourced from ClinicalTrials.gov (NCT03285529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.