Knotless Suture in Revision Total Joint Arthroplasty

NYU Langone Health

Status: Completed

Conditions: Arthroplasty

Treatments: Device: Barbed suture closure: Knee; Device: Conventional Closure: Knee; Device: Conventional Closure: Hip; Device: Barbed suture closure: Hip

Study type: Interventional

Funder types: Other

Identifiers

NCT04403919

20-00280

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥ 18 years of age
2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture

Exclusion criteria

1. Patient is ≤ 18 years of age
2. Patient is unable to provide written consent
3. Patient has active infections in the operative leg/joint
4. Known Allergy to Suture material
5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population
6. Anterior total hip replacement
7. Stage 1 of two stage revision for infection
8. Closure performed by plastic surgeon, including flap coverage

Vulnerable populations will not be enrolled in this study.

Withdrawal Criteria

1. Failure to attend regularly scheduled follow up appointments
2. Deviation from closure protocol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 4 patient groups

Revision total knee arthroplasty: control

Active Comparator group

Treatment:

Device: Conventional Closure: Knee

Revision total knee arthroplasty: active

Experimental group

Treatment:

Device: Barbed suture closure: Knee

Revision Total Hip Arthroplasty: control

Active Comparator group

Treatment:

Device: Conventional Closure: Hip

Revision Total Hip Arthroplasty: active

Experimental group

Treatment:

Device: Barbed suture closure: Hip