Status:
COMPLETED
Swelling Management After Total Knee Arthroplasty
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Colorado Joint Replacement
medi
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The purpose of this feasibility study is to estimate the initial efficacy and feasibility of an inelastic compression garment donned immediately after TKA on peak swelling in 14 subjects.
Detailed Description
Total knee arthroplasty (TKA) is the most commonly performed surgical procedure in older adults and is expected to increase five-fold by 2040 to 3.5 million TKAs annually. Although TKA is effective at...
Eligibility Criteria
Inclusion
- Scheduled to undergo a primary, unilateral total knee arthroplasty secondary to end-stage osteoarthritis
Exclusion
- Discharge to location other than home after surgery
- History of heart failure, lymphatic insufficiency, hepatic disease, pre-existing pitting edema, varicose vein ligation or any other condition associated with lower extremity swelling
- Unstable orthopedic conditions (besides OA/TKA) that limit function
- Other neurological, vascular, or cardiac problems that limit function or cause chronic lower extremity swelling
- No caregiver or inability to touch toes which can affect the ability to don/doff the compression garment
- Current smoker or history of substance abuse
- Surgical complication necessitating an altered course of rehabilitation
- Uncontrolled diabetes (hemoglobin A1c level \>8.0)
- Body mass index \>40 kg/m2
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04841356
Start Date
April 1 2021
End Date
July 14 2022
Last Update
July 21 2022
Active Locations (1)
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1
Colorado Joint Replacement
Denver, Colorado, United States, 80210