Eﬀects of Reparel™ Knee Sleeve on Knee Osteoarthritis

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 the clinical eﬀects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes 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.

- no corticosteroid knee injection for 90 days prior to consent.

- no corticosteroid knee injection for 90 days following consent.

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.	NCT04743921
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.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Additional Details

Standard knee compression sleeves have been described throughout literature to provide beneﬁts in pain and functional outcomes through support of the ligamentous structures. Bracing is both an eﬀective and economical treatment for osteoarthritis and serves as a crucial option in the treatment of knee OA to aid in both delaying surgery and as options for young patients, or patients that are not ideal surgical candidates. Although knee sleeves are commonly utilized treatment modalities, there is a signiﬁcant paucity of literature on the eﬀects of thermo-active braces in the treatment of knee OA. This investigation will examine this non-operative treatment modality and study it eﬀect for the treatment of knee OA specifically by investigating the Reparel Knee Sleeve. The Reparel Knee Sleeve is a Class I Medical Device (510(k) exempt) and used in general sports medicine practice for the alleviation of knee pain. The authors expect that the Reparel thermos-active knee sleeve will have a signiﬁcant eﬀect on pain relief from knee OA.

Arms & Interventions

Arms

Experimental: Reparel Sleeve Group

Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Interventions

Device: - Reparel Knee Sleeve

Patients who are recommended for non-operative management of knee osteoarthritis and have been consented in clinic to participate in the study will be given a Reparel™ knee sleeve to wear for knee osteoarthritis management. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Reparel™ knee sleeve, patients 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; refrain from altering treatment for knee osteoarthritis.

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.

Amit Momaya, MD, Birmingham, Alabama

Status

Address

Amit Momaya, MD

Birmingham, Alabama, 35205

Site Contact

Amit M Momaya, MD

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