Knotless Suture in Revision Total Joint Arthroplasty

Not Applicable

Completed

• Conditions: Arthroplasty

• Registration Number: NCT04403919
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-27
• Study Start: 2020-09-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Results First Submitted: 2024-03-12
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Results First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time of Closure in Minutes	Up to a maximum of 66 minutes (perioperative)	Measurement of the time needed to properly close the wound with each technique.

Secondary Outcome Measures

Name	Time	Method
Mean Length of Incision	30 minutes (perioperative)
Mean Number of Sutures Used	45 minutes (perioperative)
Incidence of Complications Related to Wound Closure	Day 90	Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.
Patient and Observer Scar Assessment Scale (POSAS) Score	Week 6 Post-Surgery	The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States