Status:
RECRUITING
Swelling Management After Knee Replacement
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Arthroplasties, Knee Replacement
Eligibility:
All Genders
50-120 years
Phase:
NA
Brief Summary
To determine if inelastic adjustable compression garment results in improved surgical limb swelling control (bioimpedance assessment - primary outcome) after TKA compared to control (TED hose).
Detailed Description
Total knee arthroplasty (TKA) is commonly performed to address disability from end-stage osteoarthritis (OA) in older adults and is expected to increase five-fold by 2040 to 3.5 million TKAs annually....
Eligibility Criteria
Inclusion
- Primary, unilateral total knee arthroplasty (TKA)
- Age 50 years or older
Exclusion
- Surgical complication necessitating an altered course of rehabilitation
- Unable to attend outpatient rehabilitation 2x/week for 3 weeks following surgery
- Inability to don/doff garment
- Neurological, cardiovascular, or unstable orthopedic conditions that limit function
- Medical conditions that cause chronic lower extremity swelling
- Contralateral TKA within past year
- Pain \>5/10 in their contralateral knee or definite plans on having their other knee replaced in the next year
- Current tobacco smoker
- Use of illegal drugs
- Uncontrolled diabetes (hemoglobin A1c level \>8.0)
- Body mass index \>40 kg/m2
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06095401
Start Date
February 21 2024
End Date
April 30 2026
Last Update
May 23 2024
Active Locations (2)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Colorado Joint Replacement
Denver, Colorado, United States, 80210