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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brett Levine, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00834483
First received: February 2, 2009
Last updated: December 2, 2012
Last verified: December 2012
  Purpose

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.

Condition Intervention
Primary Knee Arthroplasty
Primary Hip Arthroplasty
Device: Knotless suture for wound closure
Device: Layered traditional wound closure (monocryl)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • To evaluate the safety and efficacy of wound closure in primary hip and knee replacements using a bidirectional barbed suture (knotless) compared to a layered monocryl wound closure. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Establish the all around (intra-operative and postoperative)cost-savings potential in using a knotless wound closure compared to that of a layered monocryl closure (our standard suture protocol). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Assess the overall cosmesis of the wound/scar when using the knotless wound closure versus our traditional layered suture closure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Knotless suture for wound closure
Device: Knotless suture for wound closure
Angiotech Quill SRS
Other Name: Angiotech Quill SRS
Active Comparator: 2
Layered traditional wound closure (monocryl)
Device: Layered traditional wound closure (monocryl)
Layered traditional wound closure (monocryl)
Other Name: Monocryl

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834483

Locations
United States, Illinois
Rush university Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Brett R Levine, MD Rush University Medical Center
  More Information

Publications:
Responsible Party: Brett Levine, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00834483     History of Changes
Other Study ID Numbers: 08091607
Study First Received: February 2, 2009
Last Updated: December 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Safety
Efficacy
Cost-savings
Cosmesis
Safety and efficacy of wound closure
Cost-savings potential
Cosmesis of the wound/scar

ClinicalTrials.gov processed this record on August 21, 2014