Status:
COMPLETED
The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty
Lead Sponsor:
The Cleveland Clinic
Conditions:
Wound; Knee
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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 \<18 or \>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- Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03285529
Start Date
September 26 2017
End Date
May 31 2019
Last Update
November 19 2020
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195