RecruitingNot ApplicableNCT06095401

Swelling Management After Knee Replacement

Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial


Sponsor

University of Colorado, Denver

Enrollment

58 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 50 YearsMax Age: 120 Years

Inclusion Criteria2

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

Exclusion Criteria11

  • 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

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Interventions

OTHERInelastic adjustable compression garment (INCOM)

Immediately following surgery, participants randomized to INCOM will wear an inelastic adjustable compression garment set to a minimum of 30mm Hg of compression utilizing a standardized garment tensioning tool. Participants will be instructed to wear the compression garment during waking hours with a target wear time of 80% of waking hours. Participants will participate in a standardized rehabilitation program

OTHERElastic compression garment (CONTROL)

Immediately following surgery, participants randomized to CONTROL will wear a thigh-length elastic compression garment (thromboembolism-deterrent \[TED\] hose) for the first 3 weeks after TKA. Participants will be instructed to wear the compression garment during waking hours with a target wear time of 80% of waking hours. Participants will participate in a standardized rehabilitation program


Locations(2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Colorado Joint Replacement

Denver, Colorado, United States

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NCT06095401


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