Analysis of Standard Versus Barbed Sutures in Primary Total Knee Arthroplasty.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Peters, University of Utah
ClinicalTrials.gov Identifier:
NCT01320371
First received: March 18, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Arthropathy of Knee

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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.

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Intraoperative closure time in total knee arthroplasty. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost analysis in terms of operative time and material costs of closure in total knee arthroplasty. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 363
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Barbed sutures
Barbed sutures are self-anchoring, requiring no knots for wound closure.
Knotted sutures
Knotted sutures used for traditional surgical closures.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study and control groups will be made up of consecutive patients undergoing a median parapatellar approach primary total knee arthroplasty at the University of Utah Hospital and Clinics. The control group will undergo two-layer closure utilizing a standard interrupted, knotted suture technique. The closures will be performed by 2 members of the team (attending surgeon, resident, fellow, or PA) in ALL closures so as to limit the possible confounder of closure time variation due to different numbers of people closing the incision. This will specifically consist of arthrotomy closure using interrupted #1 Ethibond™ in figure of eight fashion and sudermal closure using 2-0 Monocryl™ in interrupted buried fashion.

Criteria

Inclusion Criteria:

  • Patients greater than 18 years of age
  • Undergoing primary total knee arthroplasty
  • English speaking

Exclusion Criteria:

  • Patients less than 18 years of age
  • Prior open knee surgery in close proximity (<2cm) to the proposed incision for the primary total knee arthroplasty (prior arthroscopic surgery does not exclude a patient from the study)
  • Wound or Scar in close proximity (<2cm) to the proposed incision for the primary total knee arthroplasty
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320371

Locations
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
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Christopher Peters, MD University of Utah hopsital
Principal Investigator: Jeremy Gililland, MD University of Utah Orthopaedics Resident
  More Information

No publications provided

Responsible Party: Christopher Peters, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01320371     History of Changes
Other Study ID Numbers: 44725
Study First Received: March 18, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
barbed sutures
knotted sutures
total knee arthroplasty
knee surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014