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Device

Reparel Knee Sleeve vs. TED Hose for Post-Op Recovery After Knee Surgery

N/A

Recruiting

Led By Rachael A Kilkenney, MBA,BSN

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

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

Must have

Primary unilateral Total Knee Replacement - Cruciate retaining and Posterior stabilized designs

Be older than 18 years old

Must not have

Inability to follow standardized post op and rehab protocols

Primary Inflammatory Type arthritis (i.e. rheumatoid arthritis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a new kind of post-operative garment to the current standard to see if it is more effective in reducing pain, swelling, and range of motion, as well as the need for narcotics.

Who is the study for?

This trial is for individuals who have had a total knee replacement due to osteoarthritis. They must be able to follow post-op and rehab protocols, without a history of deep vein thrombosis (DVT), vascular bypass surgery on the operative limb, lymphedema, chronic narcotic use, or leg circumference over 23 inches. Those with primary inflammatory arthritis or allergies to silicone/polyester cannot join.

What is being tested?

The study compares two methods for managing post-operative symptoms after knee replacement: a Non-Compressive Bioactive Garment (NCBG) versus standard compression stockings (TED hose). It will assess which is better at reducing pain, swelling, range of motion limitations and the need for narcotics.

What are the potential side effects?

Potential side effects may include discomfort from wearing the garments or skin reactions in case of sensitivity to garment materials like silicone or polyester. However, these are generally considered safe interventions with minimal risks.

Eligibility Criteria

Inclusion Criteria

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

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I had a knee replacement with specific design features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot follow the required after-surgery care and rehab plans.

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I have been diagnosed with a type of inflammatory arthritis, such as rheumatoid arthritis.

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My leg circumference is more than 23 inches.

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I currently have a deep vein thrombosis (DVT).

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I have had vascular bypass surgery on my leg.

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I have swelling in my arms or legs due to lymph fluid buildup.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Score (1-10)

knee society score (KSS)

leg circumference (cm)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-compressive Bioactive GarmentExperimental Treatment1 Intervention

The non-compressive bioactive garment is a commercially available garment that is designed to reflect infrared waves generated by the wearer back into the soft tissue surrounded by the garment. The reflection of the infrared waves is intended to improve pain and swelling at the site. Patients following Total knee replacement are intended to wear morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.

Group II: Thrombo-Embolic DeterrentActive Control1 Intervention

a gradient compression stocking that is currently the gold standard for deterring thromboembolic events and assisting with post-operative swelling after total knee replacements. Patients following Total knee replacement are intended to wear the TED hose morning and night for the first 2 weeks post-operatively, and then as tolerated for 4 weeks afterwards. The patients will then discontinue use of the sleeve after 6 weeks.

0 / 7Eligibility criteria met