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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834483
• Other study ID #: 08091607
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: September 9, 2014
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Device:
• Knotless suture for wound closure
Angiotech Quill SRS
• Layered traditional wound closure (monocryl)
Layered traditional wound closure (monocryl)

Locations

Country	Name	City	State
United States	Rush university Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cost-analysis	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	No
Secondary	Visual Analog Score, Cosmesis	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	No