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Completed

NCT Number: NCT01088074

A Comparative Study of Incision Closure Methods for Total Knee Replacement

The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.

The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.

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Key information

Conditions

Total Knee Replacement Closure Wound Closure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation for Southwest Orthopedic Research

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria included 18 years or older
  • TKA scheduled without a bilateral planned within one week of the initial surgery
  • Willingness to attend prescribed physical therapy 3 times per week.

Exclusion criteria

  • Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits
  • Current participation in another clinical trial
  • Preoperative systemic infections
  • Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
  • Known hypersensitivity to cyanoacrylate
  • Formaldehyde, or the dye D&C Violet #2
  • Prior knee hardware fixation devices
  • Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.

Treatment and study plan

Histoacryl Tissue Adhesive

Device

Dermabond

Device

Staples

Device

Monocryl 4-0

Device

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 1/2009-10/2009

    The primary endpoint is the mean procedure time improvement for TKA incision closure using a combined suture/adhesive or suture/staple approach versus suture closure alone.

Secondary outcomes

  1. Mean postop hospital stay

    Time frame: 1/2009-10/2009

    Change in mean postop hospital stay between study and control cohorts

Sponsors and collaborators

Lead sponsor

Foundation for Southwest Orthopedic Research

Other

Registry information

Official study title

A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 17, 2010
Registry last updated
Aug 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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