Clinical trial NCT00834483: Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties
Official title: Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Closure Time
timeFrame: 6 months
Secondary outcomes:
measure: Cost-analysis
timeFrame: 1 year
measure: Visual Analog Score, Cosmesis
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush university Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Brett R Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1089/end.2007.9913.
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.