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

September 9, 2014 updated by: Brett Levine, MD, Rush University Medical Center

Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Knotless suture for wound closure
Device: Knotless suture for wound closure
Angiotech Quill SRS
Other Names:
  • Angiotech Quill SRS
Active Comparator: 2
Layered traditional wound closure (monocryl)
Device: Layered traditional wound closure (monocryl)
Layered traditional wound closure (monocryl)
Other Names:
  • Monocryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure Time
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-analysis
Time Frame: 1 year
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
1 year
Visual Analog Score, Cosmesis
Time Frame: 6 months

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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Brett R Levine, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08091607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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