RECRUITING
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Swelling Management After Knee Replacement
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).
Conditions:
🦠 Arthroplasties, Knee Replacement
🗓️ Study Start (Actual) 21 February 2024
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 30 April 2026
👥 Enrollment (Estimated) 58
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States
📍 Denver, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Primary, unilateral total knee arthroplasty (TKA)
    • * Age 50 years or older

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 50 Years to 120 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 October 2023
  • First Submitted that Met QC Criteria 18 October 2023
  • First Posted 23 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2024
  • Last Update Posted 23 May 2024
  • Last Verified May 2024
I'm interested ...!!