Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties
- Conditions
- Hip OsteoarthritisKnee Osteoarthritis
- Interventions
- Device: Layered traditional wound closure (monocryl)Device: Knotless suture for wound closure
- Registration Number
- NCT00834483
- Lead Sponsor
- Rush University Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Patients must be male or female of any race
- Ages 18-80 years old
- Patients must be undergoing a primary hip or knee arthroplasty
- Patients must be able to understand and willing to cooperate with study procedures
- Able to provide written and verbal informed consent
- Allergy or intolerance to the study materials
- Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
- History of previous surgeries on the affected joint other than arthroscopy (open surgeries)
- History of any substance abuse or dependence within the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Layered traditional wound closure (monocryl) Layered traditional wound closure (monocryl) 1 Knotless suture for wound closure Knotless suture for wound closure
- Primary Outcome Measures
Name Time Method Closure Time 6 months 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.
- Secondary Outcome Measures
Name Time Method Cost-analysis 1 year Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs
Visual Analog Score, Cosmesis 6 months Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.
1 is an unacceptable or poor perspective in regards to wound cosmesis.
Trial Locations
- Locations (1)
Rush university Medical Center
🇺🇸Chicago, Illinois, United States