NCT04403919CompletedNot Applicable
Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Time of Closure in Minutes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥ 18 years of age
- •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
- •Patient is ≤ 18 years of age
- •Patient is unable to provide written consent
- •Patient has active infections in the operative leg/joint
- •Known Allergy to Suture material
- •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
- •Anterior total hip replacement
- •Stage 1 of two stage revision for infection
- •Closure performed by plastic surgeon, including flap coverage
- •Vulnerable populations will not be enrolled in this study.
- •Withdrawal Criteria
- •Failure to attend regularly scheduled follow up appointments
- •Deviation from closure protocol
Outcomes
Primary Outcomes
Time of Closure in Minutes
Time Frame: Up to a maximum of 66 minutes (perioperative)
Measurement of the time needed to properly close the wound with each technique.
Secondary Outcomes
- Mean Number of Sutures Used(45 minutes (perioperative))
- Mean Length of Incision(30 minutes (perioperative))
- Incidence of Complications Related to Wound Closure(Day 90)
- Patient and Observer Scar Assessment Scale (POSAS) Score(Week 6 Post-Surgery)
Investigators
Study Sites (1)
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