Reparel™ Knee Sleeve for Osteoarthritis

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Bilateral knee osteoarthritis, prior knee surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether the Reparel™ knee sleeve can help individuals with knee osteoarthritis (OA) improve mobility, functionality, and reduce pain. Osteoarthritis causes joints to become painful and stiff. The study targets those with OA visible on a knee X-ray who opt for non-surgical treatments. Participants should not have received a corticosteroid knee injection in the past 90 days and will not receive one for 90 days after joining. The researchers hope this sleeve might provide a new way to manage knee OA symptoms. As an unphased trial, it offers participants the chance to explore innovative, non-surgical options for managing knee OA symptoms.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot have had a corticosteroid injection in the knee for 90 days before joining the trial and cannot have one for 90 days after joining.

What prior data suggests that the Reparel™ Knee Sleeve is safe for treating knee osteoarthritis?

Research shows that the Reparel™ Knee Sleeve could benefit people with knee osteoarthritis. Studies have found that it can reduce arthritis pain and swelling after surgery. This sleeve is designed to be part of a non-surgical treatment plan, addressing both short-term and long-term knee inflammation.

Early results suggest that users generally tolerate the sleeve well, with no serious safety issues reported in these studies. The sleeve aims to improve movement, function, and pain relief, offering a possible alternative for those who want to manage their knee osteoarthritis without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Reparel Knee Sleeve for osteoarthritis is unique because it offers a non-invasive, drug-free approach to managing knee osteoarthritis, which sets it apart from traditional treatments like pain medications and physical therapy. Researchers are excited about this treatment because it focuses on reducing inflammation and improving blood flow through its specialized fabric technology, providing potential relief without the side effects associated with medications. Additionally, this wearable solution could be easier to integrate into daily life, offering continuous support and comfort for those suffering from knee osteoarthritis.

What evidence suggests that the Reparel Knee Sleeve is effective for knee osteoarthritis?

Studies have shown that bioactive knee sleeves, such as the Reparel™ Knee Sleeve, may help reduce pain and improve movement in people with knee osteoarthritis (OA). Research suggests these sleeves reduce swelling and support the knee, leading to easier movement and less pain. Users have reported feeling less pain and moving more easily. While more research is needed, early findings suggest that the Reparel™ Knee Sleeve could be a useful option for managing knee OA symptoms. Participants in this trial will receive the Reparel™ Knee Sleeve to evaluate its effectiveness in treating knee OA. ^{2 5 6 7 8}

Who Is on the Research Team?

Amit Momaya, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis confirmed by radiograph, who haven't had corticosteroid injections in the past 90 days and are choosing non-surgical treatments. It's not for those with prior knee surgery, both knees affected, unstable knees on exam, cancer in the knee area or hardware in the knee.

Inclusion Criteria

I am choosing a treatment that does not involve surgery.

I haven't had a corticosteroid injection in my knee in the last 90 days.

I haven't had a corticosteroid injection in my knee for the last 90 days.

Exclusion Criteria

You have some kind of metal or device in the knee being studied.

gross instability detected on physical exam

I have had surgery on the knee we are discussing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Reparel knee sleeve for treatment of knee osteoarthritis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reparel Knee Sleeve

Trial Overview The study tests if wearing a Reparel™ Knee Sleeve can improve mobility, function, and pain for people with knee osteoarthritis. The sleeve uses anti-inflammatory technology which might help manage symptoms of OA without drugs or surgery.

How Is the Trial Designed?

Group I: Reparel Sleeve Group Experimental Treatment 1 Intervention

Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04743921

Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis The purpose of this study is to determine the clinical effects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee OA.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36191914/

Bioactive Knee Sleeve for Osteoarthritis: A Small Cohort ... Conclusions: These data suggest that a bioactive sleeve may improve patient-reported pain, symptoms, and function in the setting of knee OA. Further research is ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04859764

Effect of Reparel Knee Sleeve with Knee Injection The purpose of this study is to determine if the Reparel™ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo ...

4. momayamd.com momayamd.com/pdf/bioactive-knee-sleeve-for-osteoarthritis-updated.pdf

Bioactive Knee Sleeve for Osteoarthritis: A Small Cohort ... Conclusions: These data suggest that a bioactive sleeve may improve patient-reported pain, symptoms, and function in the setting of knee. OA. Further research ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-knee-4-2021-f4393

Reparel™ Knee Sleeve for Osteoarthritis Trial Overview The study tests if wearing a Reparel™ Knee Sleeve can improve mobility, function, and pain for people with knee osteoarthritis. The sleeve uses ...

6. reparel.com reparel.com/product/knee-sleeve/

Knee Sleeve – Arthritis Pain Relief & Post-Op Recovery Reparel Knee Sleeve reduces arthritis pain, post-surgical swelling, and inflammation. Clinically backed, non-pharma recovery support for active patients.

7. trials.arthritis.org trials.arthritis.org/trials/NCT04743921

Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis The purpose of this study is to determine the clinical effects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee OA.

8. spsco.com spsco.com/reparel-knee-sleeve-1.html

Reparel Knee Sleeve Reparel Knee Sleeve is a superior option as part of a non-surgical knee pain therapy plan for acute and chronic inflammatory conditions of the knee.