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Compression Garments for Swelling After Knee Replacement Surgery

N/A

Recruiting

Led By Michael Bade, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary, unilateral total knee arthroplasty (TKA)

Age 50 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial tests if compression garments can reduce swelling after TKA surgery compared to regular stockings.

Who is the study for?

This trial is for individuals aged 50 or older who are undergoing primary, unilateral total knee arthroplasty. It's not suitable for those discharged to non-home locations post-surgery, with difficulty using the garment, other limiting orthopedic conditions, recent contralateral TKA, uncontrolled diabetes, complications altering rehab course, certain chronic conditions causing swelling or limiting function, smokers, substance abusers or those with a BMI over 40 kg/m2.Check my eligibility

What is being tested?

The study tests if an inelastic adjustable compression garment (INCOM) can better manage limb swelling after knee replacement surgery compared to a standard elastic compression garment (TED hose). Swelling control will be measured using bioimpedance assessment as the main outcome.See study design

What are the potential side effects?

While specific side effects aren't listed for these garments in this context; potential issues could include discomfort from tightness of the INCOM device and skin irritation. The actual experience may vary based on individual tolerance and proper fitting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having or have had a knee replacement on one knee only.

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I am 50 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Swelling (bioelectrical impedance)

Secondary outcome measures

30-second Sit to Stand test (30-STS)

Numeric pain rating scale

Quadriceps strength and activation testing

+3 more

Other outcome measures

Adverse Events

Satisfaction Survey

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Inelastic adjustable compression garment (INCOM)Experimental Treatment1 Intervention

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.

Group II: Elastic compression garment (CONTROL)Active Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

485 Previous Clinical Trials

1,086,842 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,468 Total Patients Enrolled

Michael Bade, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly individuals aged 85 and above meet the criteria for participating in this clinical experiment?

"This study is looking to enrol individuals aged between 50 and 120 years old."

Answered by AI

Is it possible for me to enroll in this trial?

"Requirements for enrolment in this research are that the participants must have had a knee replacement operation, be aged between 50 and 120 years old. At present, 58 people need to take part."

Answered by AI

Are there still open slots available to participants in this clinical trial?

"Unfortunately, as indicated on clinicaltrials.gov this trial is not currently enrolling participants. Although it was initially posted on November 1st 2023 and last updated October 18th 2023, there are 27 other studies that require study subjects at this current juncture."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Swelling Management After Knee Replacement

Michael Bade 2023. "Swelling Management After Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095401.