N/A
N=60
Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties
Knee Osteoarthritis · Hip Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00834483 ↗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
| 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 | — |
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
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.