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

NCT01320371 | Completed DMC

• 1 other identifier: 44725
• Study Type: observational
• Target: 363
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Arthropathy of Knee

Keywords

barbed sutures; knotted sutures; total knee arthroplasty; knee surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative closure time in total knee arthroplasty.

  6 weeks

Secondary Outcomes (1)

• Cost analysis in terms of operative time and material costs of closure in total knee arthroplasty.

  6 weeks

Study Arms (2)

Barbed sutures

Barbed sutures are self-anchoring, requiring no knots for wound closure.

Knotted sutures

Knotted sutures used for traditional surgical closures.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (4)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Joint Implant Surgeons Inc,

New Albany, Ohio, 43054, United States

Location

Scott and White HealthCare

Temple, Texas, 76508, United States

Location

University of Utah Orthopedics Center

Salt Lake City, Utah, 84106, United States

Location

Study Officials

• Christopher Peters, MD

  University of Utah hopsital

  PRINCIPAL INVESTIGATOR

• Jeremy Gililland, MD

  University of Utah Orthopaedics Resident

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

US (4)