58 Participants Needed

Compression Garments for Swelling After Knee Replacement Surgery

Recruiting at 1 trial location
MJ
Overseen ByMichael J Bade, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the treatment of compression garments for swelling after knee replacement surgery differ from other treatments?

This treatment uses inelastic adjustable compression garments, which are designed to provide consistent pressure and support, potentially reducing swelling and pain more effectively than traditional elastic compression stockings. These garments may offer a novel approach by combining the benefits of compression with adjustability, which can enhance comfort and effectiveness in managing post-surgical swelling.12345

Research Team

MB

Michael Bade, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Inclusion Criteria

I am 50 years old or older.
I am having or have had a knee replacement on one knee only.

Exclusion Criteria

I had knee replacement surgery on the opposite leg within the last year.
You have a problem with using drugs or alcohol excessively.
You are currently smoking cigarettes.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty (TKA) and are assigned to wear either an inelastic adjustable compression garment (INCOM) or elastic compression garment (TED hose) for the first three weeks post-surgery.

3 weeks
Weekly visits for assessment

Rehabilitation

Participants engage in a standardized rehabilitation program post-TKA to improve strength and function.

3 weeks

Follow-up

Participants are monitored for outcomes such as swelling, quadriceps strength, pain, ROM, and patient-reported outcomes.

12 weeks
Visits at weeks 1, 2, 3, and 12

Treatment Details

Interventions

  • Elastic compression garment (CONTROL)
  • Inelastic adjustable compression garment (INCOM)
Trial Overview 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.
Participant Groups
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.

Elastic compression garment (CONTROL) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Compression Stockings for:
  • Venous Insufficiency
  • Edema
  • Varicose Veins
  • Stasis Dermatitis
  • Post-thrombotic Syndrome
  • Lymphedema
  • Swelling Management After Surgery
🇪🇺
Approved in European Union as Compression Stockings for:
  • Chronic Venous Insufficiency
  • Lymphedema
  • Post-thrombotic Syndrome
  • Varicose Veins
  • Edema
  • Stasis Dermatitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

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

Collaborator

Trials
508
Recruited
1,090,000+

Findings from Research

In a study of 88 patients who underwent total knee arthroplasty, the use of medical elastic compression stockings did not significantly reduce knee, calf, or ankle swelling compared to no stockings over a 4-week period.
There was no difference in pain levels or patient-reported knee function between those who used the stockings and those who did not, indicating that the stockings may not provide clinical benefits after this type of surgery.
Effect of compression therapy on knee swelling and pain after total knee arthroplasty.Munk, S., Jensen, NJ., Andersen, I., et al.[2021]
Incrediwear, a non-compressive sleeve designed to enhance blood flow, significantly reduced knee effusion compared to traditional compression stockings three weeks after total knee arthroplasty, with effusion levels dropping from 1.38 to 1.12 in the Incrediwear group versus an increase from 1.16 to 1.56 in the control group.
Patients using Incrediwear also experienced better knee flexion, with a decrease of only 3% in range of motion compared to a 7% decrease in the control group, indicating that Incrediwear may support better recovery outcomes post-surgery.
Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study.Justice, TE., Jacob, PB.[2023]
This feasibility study involves 50 patients undergoing total knee arthroplasty to assess the impact of a short-stretch compression bandage on post-operative knee swelling, pain, and function compared to a standard bandage.
The study aims to gather preliminary data on the effectiveness of compression bandages, which could inform a larger trial, as current clinical data on their efficacy in knee surgery is limited.
Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study.Brock, TM., Sprowson, AP., Muller, S., et al.[2018]

References

Effect of compression therapy on knee swelling and pain after total knee arthroplasty. [2021]
Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. [2023]
Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study. [2018]
The effect of compression therapy on post-surgical swelling and pain after total knee arthroplasty. [2021]
Comparing the effectiveness of novel high-end compression garment with common compression garment and kinesio tape in preventing edema and improving tissue perfusion in lower extremities. [2023]
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