Clinical Trials Directory

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

TypeNameDescription
DEVICEKnotless suture for wound closureAngiotech Quill SRS
DEVICELayered 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.