A Comparative Study of Incision Closure Methods for Total Knee Replacement
Completed · Not applicable
Conditions studied: Total Knee Replacement Closure, Wound Closure
In brief
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.
Key facts
- Study ID
- NCT01088074
- Run by
- Foundation for Southwest Orthopedic Research
- People needed
- 75
- Starts
- 2009-01-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2012-08-22
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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°.
Where it is running
- Foundation for Southwest Orthopedic Research — Houston, Texas, United States
Full record on ClinicalTrials.gov
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