Trials / Completed
CompletedNCT00834483
Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties
Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. Closure was noted to be significantly faster (9.3 vs 13.6 minutes, P b .005) in the barbed suture group. Wound-related complications were similar (3 cases) in both groups at 3-month follow-up. Although this study supports the use of barbed technology as a functionally comparable and more efficient modality of wound closure with the potential for costs savings based on reduced operative time, the cost-effectiveness of its adoption is institution dependent and will rely on the optimization of all other perioperative factors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Knotless suture for wound closure | Angiotech Quill SRS |
| DEVICE | Layered traditional wound closure (monocryl) | Layered traditional wound closure (monocryl) |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-01-01
- Completion
- 2012-12-01
- First posted
- 2009-02-03
- Last updated
- 2014-09-11
- Results posted
- 2014-09-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00834483. Inclusion in this directory is not an endorsement.