Effect of Reparel Knee Sleeve With Knee Injection

Study Purpose

The goals of treating knee osteoarthritis (OA) is to improve or maintain quality of life, mobility and function, pain relief, and improve inflammation. The different treatment options for knee OA have been extensively studied and implemented, but the optimum treatment is still undecided. There is a belief that anti-inflammatory sleeve technology may be beneficial in treating knee OA. 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 knee sleeve in managing knee OA.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- osteoarthritis visible on knee radiograph.

- patient opting for non-surgical treatment.

Exclusion Criteria:

- bilateral symptomatic knee osteoarthritis.

- prior surgery on the knee of interest.

- hardware present on the knee of interest.

- gross instability detected on physical exam.

- malignancy in the knee of question

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04859764
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amit Momaya, MD
Principal Investigator Affiliation	University of Alabama at Birmingham
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Additional Details

Patients who are recommended non-operative management of their knee osteoarthritis and have consented to participate in the study will be randomized into two groups to receive either of the following. 1. Reparel knee sleeve. 2. Placebo knee sleeve. Participants assigned to both groups will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows:

- Wear the sleeve as much as they possibly can.

- Not change their usual activities and diet during the time they are on this study.

- Record in a diary the number of hours sleeve was worn per day.

- Record any adverse effects or discomfort due to sleeve use.

- Not to receive any injections in the subsequent 6 months following baseline randomization visit.

Participant background information that is relevant to this study will also be collected from their medical record including age, sex, and race and stored in a hospital secure computer database (REDCap). Participants will also be asked to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), Single Assessment Numeric Evaluation (SANE), Oxford Knee Score (OKS), Lysholm Score, UCLA Activity Score and Visual Analog Scale (VAS) survey questionnaires at baseline randomization visit (T0), at 4 weeks (T1), at 3 months (T2), and at 6 months (T3) to assess the mobility, functionality, and pain associated with the affected leg. The responses to the surveys will be recorded on a password-protected laptop and all patient identifiers will be replaced with unique identifier numbers. Only the study team will have access to the responses from the forms. The analysis of de-identified data will be done through SPSS 27, and scores for the questionnaires will be averaged and compared between the two groups.

Arms & Interventions

Arms

Experimental: Reparel Sleeve Group

Reparel sleeve and corticosteroid injection

Placebo Comparator: Placebo Sleeve Group

Placebo sleeve and corticosteroid injection

Interventions

Device: - Reparel knee sleeve

Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain

Drug: - Corticosteroid injection

intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)

Device: - Placebo knee sleeve

unlabeled compression knee sleeve

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UAB Hospital Highlands, Birmingham, Alabama

Status

Recruiting

Address

UAB Hospital Highlands

Birmingham, Alabama, 35205

Site Contact

Amit Momaya, MD

[email protected]

205-930-8339

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