What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly those with anti-inflammatory properties, include NSAIDs, glucocorticoid injections, and biologic therapies. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal problems. Glucocorticoid injections may provide short-term relief but can lead to joint damage and worsen long-term outcomes. Biologic therapies, such as anti-NGF agents, have been associated with rapidly progressive OA and increased rates of joint replacements. Anti-inflammatory sleeve technology, like the Reparel™ knee sleeve, aims to reduce inflammation with potentially fewer systemic side effects, but its efficacy and safety are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, including oral nonsteroidal anti-inflammatory drugs (NSAIDs) and duloxetine for patients with multiple joint OA and contraindications to NSAIDs. While anti-inflammatory sleeve technology like the Reparel™ knee sleeve is being studied for its potential benefits in improving mobility, functionality, and pain outcomes, it is not explicitly mentioned as FDA-approved in the provided context. Other investigational treatments, such as tanezumab and fasinumab, have shown some efficacy but raised safety concerns, leading to halted development.

What other types of research exist?

Promising novel alternatives to the Reparel™ knee sleeve for osteoarthritis patients in 2024 include: 1) Collagen-polyvinyl pyrrolidone (collagen-PVP), which has shown cost-utility benefits in treating knee OA compared to NSAIDs. 2) Gel-200, a cross-linked hyaluronate single-injection device, which has demonstrated safety and efficacy in clinical trials. 3) Diclofenac etalhyaluronate (DF-HA), a novel DF-conjugated hyaluronate, which has shown efficacy and safety in reducing OA pain in a phase 2 study. Additionally, non-pharmacological therapies like joint distraction and weight loss are gaining attention for their disease-modifying potential.

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Corticosteroid

Reparel Knee Sleeve + Injection for Osteoarthritis

N/A

Recruiting

Led By Amit Momaya, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

bilateral symptomatic knee osteoarthritis

prior surgery on the knee of interest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (t3)

Awards & highlights

Summary

This trial is testing a special knee brace called the Reparel™ knee sleeve to see if it helps people with knee osteoarthritis move better and feel less pain. The sleeve is thought to work by reducing swelling and supporting the knee. Patients who can't have surgery are trying this new sleeve to see if it works better than a regular one.

Who is the study for?

This trial is for individuals with knee osteoarthritis visible on X-rays who are choosing non-surgical treatments. It's not suitable for those with cancer in the affected knee, significant instability upon examination, symptoms in both knees, any hardware installed or previous surgery on the target knee.

What is being tested?

The study aims to see if wearing a Reparel™ knee sleeve can improve mobility, function, and pain better than a placebo sleeve when managing knee OA. Participants will also receive corticosteroid injections as part of their treatment.

What are the potential side effects?

Potential side effects may include skin irritation from the sleeves and typical risks associated with corticosteroid injections like joint infection, nerve damage, thinning of nearby bone (osteoporosis), tendon weakening or rupture.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have pain in both knees due to arthritis.

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I have had surgery on the knee we are discussing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (t3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (t3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (t3) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months

+15 more

Secondary study objectives

Average wear time of sleeve over past week at 3 months

Average wear time of sleeve over past week at 4 weeks

Average wear time of sleeve over past week at 6 months

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Reparel Sleeve GroupExperimental Treatment2 Interventions

Reparel sleeve and corticosteroid injection

Group II: Placebo Sleeve GroupPlacebo Group2 Interventions

Placebo sleeve and corticosteroid injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Corticosteroid injection

2018

Completed Phase 4

~1470

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteoarthritis (OA) aim to alleviate pain, reduce inflammation, and improve joint function. Nonsteroidal anti-inflammatory drugs (NSAIDs) work by inhibiting enzymes (COX-1 and COX-2) that produce prostaglandins, thereby reducing inflammation and pain. Duloxetine, an antidepressant, helps by modulating pain pathways in the central nervous system. Intraarticular glucocorticoid injections provide short-term relief by directly reducing inflammation within the joint. Anti-inflammatory sleeve technology, like the Reparel™ knee sleeve, is designed to provide continuous, localized compression and warmth, which can help reduce inflammation and improve mobility. These mechanisms are crucial for OA patients as they directly address the symptoms that most impact their quality of life, such as pain and limited mobility.

New Trends in Pharmacological Treatments for Osteoarthritis.Surgical interventions for symptomatic mild to moderate knee osteoarthritis.Primary care treatment of knee pain--a survey in older adults.