Analysis of Standard Versus Barbed Sutures in Primary Total Knee Arthroplasty.
|ClinicalTrials.gov Identifier: NCT01320371|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : February 4, 2014
The purpose of this prospective study is determine if barbed sutures are more efficient, have comparable complication rates, clinical outcomes, and cosmesis outcomes versus traditional knotted sutures when used in the closure of primary total knee arthroplasty (TKA).
Barbed suture has been associated with improved closure efficiency and safety in TKA in prior studies. The investigators performed a multicenter randomized controlled trial to determine the efficiency and safety of this technology in TKA. The investigators prospectively randomized 411 patients undergoing primary TKA to either barbed running (n=191) or knotted interrupted suture closure (n=203). Closure time was measured intraoperatively. Cost analysis was based on suture and operating room time costs.
|Condition or disease|
|Arthropathy of Knee|
Total knee arthroplasty (TKA) rates have consistently risen in recent years, and demand is expected to increase by over 600% in the next 20 years. Decreasing reimbursement and available resources make tangible advances in surgical efficiency and outcomes essential in meeting current and future demand. Closure time may be one of the best targets in the push to reduce operative time and cost while increasing operative productivity. Optimizing lengthy, multilayered wound closures in TKA is a promising means for improving both efficiency and outcomes by potentially decreasing wound closure time, reducing postoperative wound complications, and improving cosmetic outcomes.
Running knotless suture technique utilizing barbed suture technology has recently been shown to reduce wound closure time in both total hip and knee arthroplasty in a small, prospective, randomized clinical trial. Barbed suture technology has also facilitated rapid closure and soft-tissue repair in plastic-surgery literature. Very few studies have reported on the use of barbed suture technology for multilayered closure in orthopedics. As a pilot study, the investigators performed a retrospective analysis of consecutive cohorts before and after changing to barbed suture. The investigators believed that our published slight improvement in efficiency and cost savings of a barbed suture closure was underestimated due to the retrospective nature of our pilot study and the investigators therefore elected to proceed forward with a prospective randomized trial. Additionally, in the investigators pilot study we found a potential trend toward lower wound complications with the barbed suture and we wanted to see if this would be borne out in a prospective randomized trial.
The investigators hypothesized that a prospective study would show that barbed sutures would be more efficient, have comparable complication rates, clinical outcomes, and cosmesis outcomes versus traditional knotted sutures when used in the closure of primary TKA. Specifically, the investigators hypotheses were as follows: multilayered closure in TKA with barbed suture would be associated with (1) shorter closure times; (2) lower cost; (3) similar closure related perioperative complication rates; and (4) similar Knee Society, cosmesis, and patient satisfaction scores when compared to standard knotted suture closure.
|Study Type :||Observational|
|Actual Enrollment :||363 participants|
|Official Title:||Clinical Outcomes and Cost Analysis of Standard Versus Barbed Sutures for Closure in Primary Total Knee Arthroplasty: A Single Blinded Multicenter Prospective Randomized Trial.|
|Study Start Date :||January 2011|
|Primary Completion Date :||January 2014|
|Study Completion Date :||January 2014|
Barbed sutures are self-anchoring, requiring no knots for wound closure.
Knotted sutures used for traditional surgical closures.
- Intraoperative closure time in total knee arthroplasty. [ Time Frame: 6 weeks ]
- Cost analysis in terms of operative time and material costs of closure in total knee arthroplasty. [ Time Frame: 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320371
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Joint Implant Surgeons Inc,|
|New Albany, Ohio, United States, 43054|
|United States, Texas|
|Scott and White HealthCare|
|Temple, Texas, United States, 76508|
|United States, Utah|
|University of Utah Orthopedics Center|
|Salt Lake City, Utah, United States, 84106|
|Principal Investigator:||Christopher Peters, MD||University of Utah hopsital|
|Principal Investigator:||Jeremy Gililland, MD||University of Utah Orthopaedics Resident|