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N/A N=60 Randomized Double-blind Treatment

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

Knee Osteoarthritis · Hip Osteoarthritis

Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Sep 2014
Primary outcome: Primary: Closure Time — 9.34; 13.57 Average time in minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Knotless suture for wound closure (Device); Layered traditional wound closure (monocryl) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Rush University Medical Center
Primary completion
Jan 2011

Outcome Measures

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

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.

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
View full record on ClinicalTrials.gov →

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.

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