Effect of Reparel Knee Sleeve With Knee Injection

Study Overview
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Brief Summary
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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
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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 Reparel knee sleeve 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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Reparel knee sleeve
* Drug: Corticosteroid injection
* Device: Placebo knee sleeve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reparel Sleeve Group<br>Reparel sleeve and corticosteroid injection | Device: Reparel knee sleeve<br>* Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain<br>Drug: Corticosteroid injection<br>* intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)<br>* Other names: betamethasone and bupivacaine 0.5%;|
| Placebo Comparator: Placebo Sleeve Group<br>Placebo sleeve and corticosteroid injection | Drug: Corticosteroid injection<br>* intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)<br>* Other names: betamethasone and bupivacaine 0.5%;Device: Placebo knee sleeve<br>* unlabeled compression knee sleeve<br>|

What is the study measuring?
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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) | 

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) |