Trials / Completed
CompletedNCT01088074
A Comparative Study of Incision Closure Methods for Total Knee Replacement
A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Foundation for Southwest Orthopedic Research · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Histoacryl Tissue Adhesive | |
| DEVICE | Dermabond | |
| DEVICE | Staples | |
| DEVICE | Monocryl 4-0 |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2009-08-01
- Completion
- 2009-10-01
- First posted
- 2010-03-17
- Last updated
- 2012-08-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01088074. Inclusion in this directory is not an endorsement.