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: September 9, 2014
Last verified: September 2014
  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
Knee Osteoarthritis
Hip Osteoarthritis
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:
  • Closure Time [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.


Secondary Outcome Measures:
  • Cost-analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs

  • Visual Analog Score, Cosmesis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.

    1 is an unacceptable or poor perspective in regards to wound cosmesis.



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

Detailed Description:

We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. Closure was noted to be significantly faster (9.3 vs 13.6 minutes, P b .005) in the barbed suture group. Wound-related complications were similar (3 cases) in both groups at 3-month follow-up. Although this study supports the use of barbed technology as a functionally comparable and more efficient modality of wound closure with the potential for costs savings based on reduced operative time, the cost-effectiveness of its adoption is institution dependent and will rely on the optimization of all other perioperative factors.

  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
Results First Received: February 2, 2013
Last Updated: September 9, 2014
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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014