Recruiting

Swelling Management

Sponsor:

University of Colorado, Denver

Code:

NCT06095401

Conditions

Arthroplasties, Knee Replacement

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Inelastic adjustable compression garment (INCOM)

Elastic compression garment (CONTROL)

Study Details

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).

Conditions

Arthroplasties, Knee Replacement

Study ID

NCT06095401

Start date

Feb 21, 2024

Status verified date

May, 2024

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inelastic adjustable compression garment (INCOM)

Subjects randomized to the INCOM group will have a CircAid Juxtafit upper leg and knee garment combined with a lower leg garment (Medi USA, Whitsett, NC) applied to their limb at a minimum of 30mm Hg utilizing a standardized garment tensioning tool.

The experimental group will be instructed to wear their garments during all waking hours with a target wear time of >80% of waking hours for the first three weeks after surgery.

active comparator: Elastic compression garment (CONTROL)

Subjects randomized to the CONTROL group will have a thigh-length elastic compression garment (thromboembolism-deterrent \[TED\] hose) applied to their limb. The control group will be instructed to wear their garments during all waking hours with a target wear time of >80% waking hours for the first three weeks after surgery.

Interventions

Inelastic 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

Elastic 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

Primary outcome measure

  • Swelling (bioelectrical impedance) [ Time Frame: Baseline testing will occur 2-14 days prior to TKA at the Portercare Adventist campus. Postoperative testing will occur at weeks 1, 2, 3 (primary endpoint), and 12. ]

Central Contacts and Locations

Central contacts

Michael J Bade, PhD

303-724-9590michael.bade@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Michael Bade, PhD, DPT

303-724-9025michael.bade@cuanschutz.edu

Colorado Joint Replacement

Recruiting

Denver, Colorado, United States, 80210

Contacts

Roseann Johnson, BS

303-260-2940roseann.johnson@adventhealth.com

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 23, 2024

Last verified

May, 2024

Keywords

  • swelling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-05-23.