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

NCT ID: NCT00834483

Last Updated: 2014-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-12-31

Brief 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.

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Knotless suture for wound closure

Group Type: EXPERIMENTAL

Knotless suture for wound closure

Intervention Type: DEVICE

Angiotech Quill SRS

2

Layered traditional wound closure (monocryl)

Group Type: ACTIVE_COMPARATOR

Layered traditional wound closure (monocryl)

Intervention Type: DEVICE

Layered traditional wound closure (monocryl)

Interventions

Knotless suture for wound closure

Angiotech Quill SRS

Intervention Type: DEVICE

Layered traditional wound closure (monocryl)

Layered traditional wound closure (monocryl)

Intervention Type: DEVICE

Other Intervention Names

Angiotech Quill SRS; Monocryl

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brett Levine, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett R Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush university Medical Center

Chicago, Illinois, United States

Countries

United States

References

Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.

Reference Type: BACKGROUND

PMID: 18619922 (View on PubMed)

Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007 Oct;21(10):1175-8. doi: 10.1089/end.2007.9913.

Reference Type: BACKGROUND

PMID: 17949320 (View on PubMed)

Villa MT, White LE, Alam M, Yoo SS, Walton RL. Barbed sutures: a review of the literature. Plast Reconstr Surg. 2008 Mar;121(3):102e-108e. doi: 10.1097/01.prs.0000299452.24743.65.

Reference Type: BACKGROUND

PMID: 18317092 (View on PubMed)

Other Identifiers

08091607

Identifier Type: -

Identifier Source: org_study_id