Compression Garments for Swelling After Knee Replacement Surgery

Recruiting at 1 trial location

Overseen By Michael J Bade, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Neurological, cardiovascular, orthopedic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a special compression garment can better manage leg swelling after knee replacement surgery. Participants will be divided into two groups: one will use a regular elastic stocking (also known as a compression stocking or support hose), and the other will try an adjustable compression garment (referred to as INCOM or inelastic adjustable compression garment). The trial seeks individuals who have had a single knee replaced and can attend rehab sessions. It aims to assist those experiencing significant swelling after surgery and interested in trying a new management method. As an unphased trial, this study offers participants the chance to explore innovative solutions for managing post-surgery swelling.

Will I have to stop taking my current medications?

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

What prior data suggests that these compression garments are safe for use after knee replacement surgery?

Research has shown that inelastic compression garments, like the one under study, are generally safe for individuals who have undergone knee replacement surgery. Studies have found no major differences in complications or pain compared to other treatments. Patients have reported satisfaction and adherence to wearing these garments.

This trial tests an adjustable inelastic garment to determine if it controls swelling better than the usual elastic compression garment. Both types are intended for most of the day after surgery and are considered safe. While this trial specifically tests the inelastic garment, earlier studies suggest it is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these compression garments for managing swelling after knee replacement surgery because they offer unique benefits compared to traditional options like standard elastic compression stockings. The inelastic adjustable compression garment (INCOM) stands out by providing customizable pressure levels using a standardized tensioning tool, potentially enhancing comfort and effectiveness. This tailored fit could lead to better control of swelling and improved patient outcomes during recovery. Meanwhile, the elastic compression garment (CONTROL) serves as a reliable baseline, ensuring that any benefits from the INCOM can be clearly attributed to its innovative design.

What evidence suggests that these compression garments are effective for controlling swelling after knee replacement surgery?

Research has shown that inelastic adjustable compression garments, which participants in this trial may receive, can help reduce leg swelling. One study found that these garments significantly reduced swelling in people with long-term leg issues. Another study noted a decrease in knee swelling with compression therapy, though the change wasn't large enough to be statistically significant. These garments apply steady pressure, improving blood flow and reducing fluid build-up to manage swelling. Users often find them more comfortable and easier to care for than traditional elastic options, used in the control arm of this trial. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Bade, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Inelastic adjustable compression garment (INCOM) Experimental Treatment 1 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 Control 1 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

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+

Published Research Related to This Trial

In a pilot study involving 44 patients after total knee arthroplasty, the use of graduated medical elastic thigh compression stockings did not show a statistically significant difference in reducing swelling or pain compared to standard treatment.

Despite the lack of significant results, the study suggests that compression stockings may have a positive effect on reducing swelling, indicating the need for a larger study to further investigate their effectiveness, especially with improved patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of compression therapy on post-surgical swelling and pain after total knee arthroplasty. Christensen, LMR., Arnesen, CE., Möller, S., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The novel high-end compression stocking significantly reduced edema in the knee region after 6 hours of use, showing a positive correlation between higher compression pressure and volume decrease, although it did not outperform the common compression stocking or kinesio tape in a broader comparison.

Kinesio tape did not demonstrate any benefits in preventing edema, improving circulation, or enhancing range of motion in the lower limbs, indicating that its effectiveness may be limited compared to traditional compression garments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Diesch, ST., Schiltz, D., Kammermeier, J., et al.[2023]

Citations

1.

amazon.com

amazon.com/Sigvaris-CoolFlex-Inelastic-Compression-Garment/dp/B07F9T9WR5

Sigvaris COOLFLEX No Foot Below Knee Inelastic ...

We monitor compression levels and measurements closely and produce precisely so you can be sure you're getting an effective and comfortable garment. Why do we ...

2.

sigvaris.com

sigvaris.com/en-us/catalog/product-styles/lymphedema-garments/compreflex-contain-knee-adjustable-compression-device-for-the-knee

Compreflex Contain Knee - Lymphedema garments

Sigvaris Compreflex Contain Knee adjustable inelastic compression garment for the treatment of lymphedema, edema, lipedema.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38866131/

Benefits of an Adjustable Compression Garment System for ...

The ACG used in this study was found to promote self-care in a high proportion of patients with chronic leg oedema. A significant reduction in oedema was ...

4.

aetna.com

aetna.com/cpb/medical/data/400_499/0482.html

Compression Garments for the Legs

Fabric support garments are stockings or sleeves, usually made of elastic that may be utilized for, but not limited to, cases of severe edema, prevention of ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33339752/

The effect of compression therapy on post-surgical swelling ...

Knee swelling was reduced in both groups after 14 days, but was slightly more in the intervention group. The result is not statistically significant but ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5223465/

Short-sTretch Inelastic Compression bandage in Knee ...

There was no significant difference between groups regarding knee swelling, knee range of motion, visual analogue pain score, complications and ...

7.

jctres.com

jctres.com/media/downloads/jctr2400026/%5B3%5D%20JCTR_v10i5_004%20-%20Proof%203.0%20(finalized).pdf

Immediate inelastic compression garment for swelling ...

Patients experience significant swelling after total knee arthroplasty (TKA). Swelling increases 10%/day, on average, for the first 3 days after ...

8.

accscience.com

accscience.com/journal/JCTR/10/5/10.36922/jctr.24.00026

Immediate inelastic compression garment for swelling ...

ICG feasibility outcomes at day 21 were safety, satisfaction, and adherence. Initial efficacy outcomes at days 4, 7, 14, 21, and 42 were swelling, quadriceps ...

9.

researchgate.net

researchgate.net/publication/330588445_Development_of_a_reference_chart_to_monitor_postoperative_swelling_following_total_knee_arthroplasty

Development of a reference chart to monitor postoperative ...

The reference chart provides a novel framework for monitoring swelling following total knee arthroplasty and may augment clinical decisions.

10.

oarsiopenjournal.com

oarsiopenjournal.com/article/S2665-9131(23)00096-1/fulltext

The past and future of peri-operative interventions to reduce ...

This suggests that an inelastic compression garment may improve knee swelling after TKA–however, further research is needed given the limitations ...