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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)

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.
Select...
I have had surgery on the knee we are discussing.

Timeline

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
~1510

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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,649 Previous Clinical Trials
2,345,635 Total Patients Enrolled
8 Trials studying Osteoarthritis
44,558 Patients Enrolled for Osteoarthritis
Amit Momaya, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
3 Previous Clinical Trials
174 Total Patients Enrolled
1 Trials studying Osteoarthritis
14 Patients Enrolled for Osteoarthritis

Media Library

Corticosteroid injection (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04859764 — N/A
Osteoarthritis Research Study Groups: Reparel Sleeve Group, Placebo Sleeve Group
Osteoarthritis Clinical Trial 2023: Corticosteroid injection Highlights & Side Effects. Trial Name: NCT04859764 — N/A
Corticosteroid injection (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04859764 — N/A
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