NCT04403919

Knotless Suture in Revision Total Joint Arthroplasty

Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.

Conditions

• Arthroplasty

Interventions

Type	Name	Description
DEVICE	Conventional Closure: Knee	Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
DEVICE	Barbed suture closure: Knee	The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
DEVICE	Conventional Closure: Hip	1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
DEVICE	Barbed suture closure: Hip	1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-05-27
• Last updated: 2024-04-17
• Results posted: 2024-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study