Effect of Reparel Knee Sleeve With Knee Injection

Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Reparel knee sleeve; Drug: Corticosteroid injection; Device: Placebo knee sleeve

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Hospital Highlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reparel Sleeve Group; Reparel sleeve and corticosteroid injection	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); Other Names: betamethasone and bupivacaine 0.5%
Placebo Comparator: Placebo Sleeve Group; Placebo sleeve and corticosteroid injection	Drug: Corticosteroid injection; intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size); Other Names: betamethasone and bupivacaine 0.5%; Device: Placebo knee sleeve; unlabeled compression knee sleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks	activity score, 1-10, 10 is best outcome	4 weeks (T1)
Change in University of California, Los Angeles (UCLA) Activity Score at 3 months	activity score, 1-10, 10 is best outcome	3 months (T2)
Change in University of California, Los Angeles (UCLA) Activity Score at 6 months	activity score, 1-10, 10 is best outcome	6 months (T3)
Change in Lysholm Score at 4 weeks	ability to manage activities of daily living, 0-100, 100 is best outcome	4 weeks (T1)
Change in Lysholm Score at 3 months	ability to manage activities of daily living, 0-100, 100 is best outcome	3 months (T2)
Change in Lysholm Score at 6 months	ability to manage activities of daily living, 0-100, 100 is best outcome	6 months (T3)
Change in Oxford Knee Score (OKS) at 4 weeks	knee pain and function score, 0-48, 48 is best outcome	4 weeks (T1)
Change in Oxford Knee Score (OKS) at 3 months	knee pain and function score, 0-48, 48 is best outcome	3 months (T2)
Change in Oxford Knee Score (OKS) at 6 months	knee pain and function score, 0-48, 48 is best outcome	6 months (T3)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks	knee pain and function score, 0-100, 100 is best outcome	4 weeks (T1)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months	knee pain and function score, 0-100, 100 is best outcome	3 months (T2)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months	knee pain and function score, 0-100, 100 is best outcome	6 months (T3)
Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks	function score, 0-100%, 100% is best outcome	4 weeks (T1)
Change in Single Assessment Numeric Evaluation (SANE) at 3 months	function score, 0-100%, 100% is best outcome	3 months (T2)
Change in Single Assessment Numeric Evaluation (SANE) at 6 months	function score, 0-100%, 100% is best outcome	6 months (T3)
Change in Visual Analog Scale (VAS) at 4 weeks	pain score, 0-10, 10 is best outcome	4 weeks (T1)
Change in Visual Analog Scale (VAS) at 3 months	pain score, 0-10, 10 is best outcome	3 months (T2)
Change in Visual Analog Scale (VAS) at 6 months	pain score, 0-10, 10 is best outcome	6 months (T3)
Need for Additional CSI	need for additional CSI after baseline injection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with knee sleeve at 4 weeks	0-10, 10 is best	4 weeks (T1)
Satisfaction with knee sleeve at 3 months	0-10, 10 is best	3 months (T2)
Satisfaction with knee sleeve at 6 months	0-10, 10 is best	6 months (T3)
Average wear time of sleeve over past week at 4 weeks	0-24 hours, 24 hours is best	4 weeks (T1)
Average wear time of sleeve over past week at 3 months	0-24 hours, 24 hours is best	3 months (T2)
Average wear time of sleeve over past week at 6 months	0-24 hours, 24 hours is best	6 months (T3)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Amit Momaya, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Betamethasone; Adrenal Cortex Hormones
• Other Study ID Numbers: IRB-300006118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No