RECRUITING

Swelling Management After Knee Replacement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial

Quick Facts

Study Start:2024-02-21
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06095401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary, unilateral total knee arthroplasty (TKA)
  2. * Age 50 years or older
  1. * Surgical complication necessitating an altered course of rehabilitation
  2. * Unable to attend outpatient rehabilitation 2x/week for 3 weeks following surgery
  3. * Inability to don/doff garment
  4. * Neurological, cardiovascular, or unstable orthopedic conditions that limit function
  5. * Medical conditions that cause chronic lower extremity swelling
  6. * Contralateral TKA within past year
  7. * Pain \>5/10 in their contralateral knee or definite plans on having their other knee replaced in the next year
  8. * Current tobacco smoker
  9. * Use of illegal drugs
  10. * Uncontrolled diabetes (hemoglobin A1c level \>8.0)
  11. * Body mass index \>40 kg/m2

Contacts and Locations

Study Contact

Michael J Bade, PhD
CONTACT
303-724-9590
michael.bade@cuanschutz.edu

Principal Investigator

Michael Bade, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Colorado Joint Replacement
Denver, Colorado, 80210
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Michael Bade, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

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

Study Start Date2024-02-21
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-02-21
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • swelling

Additional Relevant MeSH Terms

  • Arthroplasties, Knee Replacement