Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial

Conditions
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Knee Osteoarthritis, Hip Osteoarthritis

Intervention / Treatment
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* Device: Knotless suture for wound closure
* Device: Layered traditional wound closure (monocryl)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Knotless suture for wound closure | Device: Knotless suture for wound closure<br>* Angiotech Quill SRS<br>* Other names: Angiotech Quill SRS;|
| Active Comparator: 2<br>Layered traditional wound closure (monocryl) | Device: Layered traditional wound closure (monocryl)<br>* Layered traditional wound closure (monocryl)<br>* Other names: Monocryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure Time | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-analysis | 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 | 1 year | 
| Visual Analog Score, Cosmesis | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Efficacy, Cost-savings, Cosmesis, Safety and efficacy of wound closure, Cost-savings potential, Cosmesis of the wound/scar