Compression Garments for Swelling After Knee Replacement Surgery
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
How does the treatment of compression garments for swelling after knee replacement surgery differ from other treatments?
This treatment uses inelastic adjustable compression garments, which are designed to provide consistent pressure and support, potentially reducing swelling and pain more effectively than traditional elastic compression stockings. These garments may offer a novel approach by combining the benefits of compression with adjustability, which can enhance comfort and effectiveness in managing post-surgical swelling.12345
Research Team
Michael Bade, PhD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for individuals aged 50 or older who are undergoing primary, unilateral total knee arthroplasty. It's not suitable for those discharged to non-home locations post-surgery, with difficulty using the garment, other limiting orthopedic conditions, recent contralateral TKA, uncontrolled diabetes, complications altering rehab course, certain chronic conditions causing swelling or limiting function, smokers, substance abusers or those with a BMI over 40 kg/m2.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo total knee arthroplasty (TKA) and are assigned to wear either an inelastic adjustable compression garment (INCOM) or elastic compression garment (TED hose) for the first three weeks post-surgery.
Rehabilitation
Participants engage in a standardized rehabilitation program post-TKA to improve strength and function.
Follow-up
Participants are monitored for outcomes such as swelling, quadriceps strength, pain, ROM, and patient-reported outcomes.
Treatment Details
Interventions
- Elastic compression garment (CONTROL)
- Inelastic adjustable compression garment (INCOM)
Elastic compression garment (CONTROL) is already approved in United States, European Union for the following indications:
- Venous Insufficiency
- Edema
- Varicose Veins
- Stasis Dermatitis
- Post-thrombotic Syndrome
- Lymphedema
- Swelling Management After Surgery
- Chronic Venous Insufficiency
- Lymphedema
- Post-thrombotic Syndrome
- Varicose Veins
- Edema
- Stasis Dermatitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator