Effect of Reparel Knee Sleeve With Knee Injection

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859764
• Other study ID #: IRB-300006118
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Amit Momaya, MD
• Phone: +1 (205) 975-2663
• Email: amit.momaya[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	UAB Hospital Highlands	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks	activity score, 1-10, 10 is best outcome	4 weeks (T1)
Primary	Change in University of California, Los Angeles (UCLA) Activity Score at 3 months	activity score, 1-10, 10 is best outcome	3 months (T2)
Primary	Change in University of California, Los Angeles (UCLA) Activity Score at 6 months	activity score, 1-10, 10 is best outcome	6 months (T3)
Primary	Change in Lysholm Score at 4 weeks	ability to manage activities of daily living, 0-100, 100 is best outcome	4 weeks (T1)
Primary	Change in Lysholm Score at 3 months	ability to manage activities of daily living, 0-100, 100 is best outcome	3 months (T2)
Primary	Change in Lysholm Score at 6 months	ability to manage activities of daily living, 0-100, 100 is best outcome	6 months (T3)
Primary	Change in Oxford Knee Score (OKS) at 4 weeks	knee pain and function score, 0-48, 48 is best outcome	4 weeks (T1)
Primary	Change in Oxford Knee Score (OKS) at 3 months	knee pain and function score, 0-48, 48 is best outcome	3 months (T2)
Primary	Change in Oxford Knee Score (OKS) at 6 months	knee pain and function score, 0-48, 48 is best outcome	6 months (T3)
Primary	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)
Primary	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)
Primary	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)
Primary	Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks	function score, 0-100%, 100% is best outcome	4 weeks (T1)
Primary	Change in Single Assessment Numeric Evaluation (SANE) at 3 months	function score, 0-100%, 100% is best outcome	3 months (T2)
Primary	Change in Single Assessment Numeric Evaluation (SANE) at 6 months	function score, 0-100%, 100% is best outcome	6 months (T3)
Primary	Change in Visual Analog Scale (VAS) at 4 weeks	pain score, 0-10, 10 is best outcome	4 weeks (T1)
Primary	Change in Visual Analog Scale (VAS) at 3 months	pain score, 0-10, 10 is best outcome	3 months (T2)
Primary	Change in Visual Analog Scale (VAS) at 6 months	pain score, 0-10, 10 is best outcome	6 months (T3)
Secondary	Satisfaction with knee sleeve at 4 weeks	0-10, 10 is best	4 weeks (T1)
Secondary	Satisfaction with knee sleeve at 3 months	0-10, 10 is best	3 months (T2)
Secondary	Satisfaction with knee sleeve at 6 months	0-10, 10 is best	6 months (T3)
Secondary	Average wear time of sleeve over past week at 4 weeks	0-24 hours, 24 hours is best	4 weeks (T1)
Secondary	Average wear time of sleeve over past week at 3 months	0-24 hours, 24 hours is best	3 months (T2)
Secondary	Average wear time of sleeve over past week at 6 months	0-24 hours, 24 hours is best	6 months (T3)