Effect of Reparel Knee Sleeve With Knee Injection

NCT ID: NCT04859764

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2025-12-03

Brief Summary

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.

Detailed Description

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reparel Sleeve Group

Reparel sleeve and corticosteroid injection

Group Type: EXPERIMENTAL

Reparel knee sleeve

Intervention Type: DEVICE

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

Corticosteroid injection

Intervention Type: DRUG

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

Placebo Sleeve Group

Placebo sleeve and corticosteroid injection

Group Type: PLACEBO_COMPARATOR

Corticosteroid injection

Intervention Type: DRUG

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

Placebo knee sleeve

Intervention Type: DEVICE

unlabeled compression knee sleeve

Interventions

Reparel knee sleeve

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

Intervention Type: DEVICE

Corticosteroid injection

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

Intervention Type: DRUG

Placebo knee sleeve

unlabeled compression knee sleeve

Intervention Type: DEVICE

Other Intervention Names

betamethasone and bupivacaine 0.5%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Amit Momaya

Assistant Professor, Section Chief, Sports Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Momaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Hospital Highlands

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300006118

Identifier Type: -

Identifier Source: org_study_id