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

NCT00834483 | Completed Results DMC

• 1 other identifier: 08091607
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Keywords

Safety; Efficacy; Cost-savings; Cosmesis; Safety and efficacy of wound closure; Cost-savings potential; Cosmesis of the wound/scar

Outcome Measures

Primary Outcomes (1)

• Closure Time

  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 Outcomes (2)

• Cost-analysis

  1 year

• Visual Analog Score, Cosmesis

  6 months

Study Arms (2)

1

EXPERIMENTAL

Knotless suture for wound closure

Device: Knotless suture for wound closure

2

ACTIVE COMPARATOR

Layered traditional wound closure (monocryl)

Device: Layered traditional wound closure (monocryl)

Interventions

Knotless suture for wound closure DEVICE

Angiotech Quill SRS

Also known as: Angiotech Quill SRS

1

Layered traditional wound closure (monocryl) DEVICE

Layered traditional wound closure (monocryl)

Also known as: Monocryl

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush university Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

• 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.

  PMID: 18619922 BACKGROUND

• 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.

  PMID: 17949320 BACKGROUND

• 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.

  PMID: 18317092 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Five patients were offered enrollment but refused to participate, however this does not alter our data as sixty others did enroll.

Results Point of Contact

• Title: Dr. Brett R. Levine
• Organization: Rush University Medical Center

brettlevine@gmail.com

312-432-2466

Study Officials

• Brett R Levine, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 11, 2014
• Results First Posted: September 11, 2014

Record last verified: 2014-09

Locations

US (1)