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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
patient opting for non-surgical treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months (t3)
Awards & highlights

Study Summary

This trial is testing if a new knee sleeve, Reparel™, is better than a placebo sleeve in treating knee osteoarthritis in terms of mobility, functionality, and pain relief.

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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am choosing a treatment that does not involve surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
~1410

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,337 Total Patients Enrolled
8 Trials studying Osteoarthritis
44,604 Patients Enrolled for Osteoarthritis
Amit Momaya, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Osteoarthritis
60 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit of individuals participating in this experiment?

"Affirmative. Clinicaltrials.gov attests to this clinical trial's ongoing status, which began on June 29th 2022 and was most recently amended on November 30th 2022. It is now in the process of recruiting 74 individuals from one medical facility."

Answered by AI

What are the ultimate goals that researchers hope to accomplish with this trial?

"The primary measure of success, assessed over 3 months (T2), is the shift in Visual Analog Scale scores at 6 month intervals. Additionally, researchers will be looking to gauge Average wear time, Satisfaction with knee sleeve and more all within a 6-month period."

Answered by AI

Is there any way I can become a test subject for this experiment?

"This trial is searching for 74 individuals who are suffering from osteoarthritis in their knee and fit the age range of 18-99. Meeting these criteria will qualify them to join this study."

Answered by AI

Are there currently opportunities for participants to join this experiment?

"Affirmative. Evidence on clinicaltrials.gov indicates that this experiment, which was created on June 29th 2022, is still recruiting participants. 74 test subjects are required from one medical centre."

Answered by AI

Are individuals aged 50 and above being accepted in this clinical trial?

"This medical study is recruiting any patient above the age of consent and younger than 99 years old."

Answered by AI
~36 spots leftby Dec 2025