Managing swelling after knee replacement surgery
Swelling Management After Total Knee Arthroplasty: A Randomized Controlled Trial
This study is testing if a special adjustable compression garment can help reduce swelling in the knee after surgery better than regular compression stockings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 50 Years to 120 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06095401 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an inelastic adjustable compression garment in controlling swelling in the surgical limb after total knee arthroplasty (TKA) compared to traditional TED hose. The primary outcome will be assessed through bioimpedance measurements to quantify swelling. Given the significant increase in knee swelling post-surgery, which can lead to long-term functional decline, this study seeks to improve postoperative recovery and outcomes. Participants will be monitored for their ability to attend rehabilitation sessions and manage the compression garment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 years or older who are scheduled for primary, unilateral total knee arthroplasty.
Not a fit: Patients with surgical complications, chronic swelling conditions, or those unable to participate in rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and functional outcomes for patients undergoing knee replacement surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing postoperative swelling and improving recovery outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Colorado Joint Replacement — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Michael Bade, PhD — University of Colorado, Denver
- Study coordinator: Michael J Bade, PhD
- Email: michael.bade@cuanschutz.edu
- Phone: 303-724-9590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.