Reparel Knee Sleeve + Injection for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
Is the Reparel Knee Sleeve + Injection treatment safe for humans?
Triamcinolone acetonide extended-release, used for knee osteoarthritis, is generally well tolerated with a safety profile similar to placebo. However, local corticosteroid injections can sometimes cause side effects like skin color changes, muscle wasting, and tendon issues, especially if not administered properly.12345
How is the Reparel Knee Sleeve + Injection treatment for osteoarthritis different from other treatments?
The Reparel Knee Sleeve + Injection treatment combines a corticosteroid injection, which provides rapid symptom relief by reducing inflammation, with a Reparel knee sleeve that may offer additional support and comfort. This combination aims to enhance the overall effectiveness and comfort compared to using corticosteroid injections alone.14678
What data supports the effectiveness of the treatment Reparel Knee Sleeve + Injection for Osteoarthritis?
Research shows that triamcinolone acetonide extended-release injections significantly improve pain, stiffness, and physical function in knee osteoarthritis compared to placebo, with effects lasting up to 24 weeks. This suggests that corticosteroid injections, a component of the treatment, can be effective in managing osteoarthritis symptoms.147910
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 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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either the Reparel knee sleeve or a placebo knee sleeve, along with corticosteroid injection. They are instructed to wear the sleeve as much as possible and maintain a diary of usage and any adverse effects.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments using various scores such as KOOS, SANE, OKS, Lysholm, UCLA Activity Score, and VAS.
What Are the Treatments Tested in This Trial?
Interventions
- Corticosteroid injection
- Placebo knee sleeve
- Reparel knee sleeve
Corticosteroid injection is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Asthma
- COPD
- Rheumatoid arthritis
- Osteoarthritis
- Bursitis
- Tendonitis
- Skin conditions
- Eye conditions
- Gastrointestinal disorders
- Allergic reactions
- Asthma
- COPD
- Rheumatoid arthritis
- Osteoarthritis
- Bursitis
- Tendonitis
- Skin conditions
- Eye conditions
- Gastrointestinal disorders
- Allergic reactions
- Asthma
- COPD
- Rheumatoid arthritis
- Osteoarthritis
- Bursitis
- Tendonitis
- Skin conditions
- Eye conditions
- Gastrointestinal disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor