Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis

The University of Alabama at Birmingham

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: Reparel Knee Sleeve

Study type: Interventional

Funder types: Other

Identifiers

NCT04743921

IRB-300006549

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Reparel Sleeve Group

Experimental group

Description:

Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Treatment:

Device: Reparel Knee Sleeve