Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties
NCT00834483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2014-09-11
Summary
Barbed sutures offer several potential advantages in layered wound closure of hip and knee replacement surgeries. It use is gaining increased acceptance across many of the other surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill as part of our layered closure compared to using our traditional sutures. The study timeline begins at the time of the surgical procedure and continues through the routine follow-up of total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month post-operative office visit.
Primary Objectives:
* To evaluate the safety and efficacy of wound closure in primary hip and knee replacements using a bidirectional barbed suture (knotless) compared to a traditional layered (vicryl) wound closure.
Secondary Objectives:
* Establish the all around (intra-operative and post-operative) cost-savings potential in using a knotless wound closure compared to that of a layered vicryl closure (our standard suture protocol).
* Assess the overall cosmesis of the wound/scar as well as perceived presence of subcutaneous surgical knots, when using the knotless wound closure versus our traditional layered suture closure.
Conditions
- Knee Osteoarthritis
- Hip Osteoarthritis
Interventions
- DEVICE
-
Knotless suture for wound closure
Angiotech Quill SRS
- DEVICE
-
Layered traditional wound closure (monocryl)
Layered traditional wound closure (monocryl)
Sponsors & Collaborators
-
Rush University Medical Center
lead OTHER
Principal Investigators
-
Brett R Levine, MD · Rush University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-02-28
- Primary Completion
- 2011-01-31
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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