N/A N=81 Randomized Other

Knotless Suture in Revision Total Joint Arthroplasty

Arthroplasty

Bottom Line

View on ClinicalTrials.gov: NCT04403919 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Apr 2024

Primary outcome: Primary: Time of Closure in Minutes — 36.3; 31.1; 35.9; 27.1 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Conventional Closure: Knee (Device); Barbed suture closure: Knee (Device); Conventional Closure: Hip (Device); Barbed suture closure: Hip (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Time of Closure in Minutes	36.3; 31.1; 35.9; 27.1	—
SECONDARY Incidence of Complications Related to Wound Closure	2; 4; 1; 0	—
SECONDARY Patient and Observer Scar Assessment Scale (POSAS) Score	2.7; 3.4; 2.5; 2.6	—
SECONDARY Mean Number of Sutures Used	10.9; 6.3; 9.1; 5.9	—
SECONDARY Mean Length of Incision	196.4; 186; 168; 177	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04403919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.