Prospective Randomized Trial of Stratafix vs. Vicryl in Total Hip Arthroplasty.

Completed · Not applicable

Conditions studied: Wound; Hip

In brief

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.

Key facts

Study ID

NCT03285555

Run by

The Cleveland Clinic

People needed

60

Starts

2017-09-26

Expected to finish

2019-08-31

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 hip arthroplasty
• BMI less than 40 kg/m2

You may not qualify if…

• 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• Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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