Total Knee Replacement Closure, Wound Closure
Conditions
Keywords
Total Knee Replacement, Closure Methods
Brief summary
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.
Sponsors
Foundation for Southwest Orthopedic Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean postop hospital stay | 1/2009-10/2009 | Change in mean postop hospital stay between study and control cohorts |
Countries
United States
Outcome results
None listed