N/A Completed N=60 Randomized Double-blind Treatment

Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties

Knee Osteoarthritis · Hip Osteoarthritis

Source: ClinicalTrials.gov NCT00834483 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Sep 2014

Primary outcomePrimary: Closure Time — 9.34; 13.57 Average time in minutes

Summary

Barbed sutures offer several potential advantages in layered wound closure of hip and knee replacement surgeries. It use is gaining increased acceptance across many of the other surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill as part of our layered closure compared to using our traditional sutures. The study timeline begins at the time of the surgical procedure and continues through the routine follow-up of total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month post-operative office visit. Primary Objectives: * To evaluate the safety and efficacy of wound closure in primary hip and knee replacements using a bidirectional barbed suture (knotless) compared to a traditional layered (vicryl) wound closure. Secondary Objectives: * Establish the all around (intra-operative and post-operative) cost-savings potential in using a knotless wound closure compared to that of a layered vicryl closure (our standard suture protocol). * Assess the overall cosmesis of the wound/scar as well as perceived presence of subcutaneous surgical knots, when using the knotless wound closure versus our traditional layered suture closure.

Outcome Measures

Outcome	Result	p-value
PRIMARY Closure Time	9.34; 13.57	—
SECONDARY Cost-analysis	52.75; 12.79	—
SECONDARY Visual Analog Score, Cosmesis	5.9; 5.8	—

Eligibility Criteria

Inclusion Criteria

Patients must be male or female of any race
Ages 18-80 years old
Patients must be undergoing a primary hip or knee arthroplasty
Patients must be able to understand and willing to cooperate with study procedures
Able to provide written and verbal informed consent

Exclusion Criteria

Allergy or intolerance to the study materials
Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
History of previous surgeries on the affected joint other than arthroscopy (open surgeries)
History of any substance abuse or dependence within the last 6 months

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Data sourced from ClinicalTrials.gov (NCT00834483). 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. Informational only — not medical advice.