Effect of Reparel Knee Sleeve With Knee Injection
Purpose
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.
Condition
- Osteoarthritis, Knee
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Unmarked sleeves will be used. Half will be Reparel sleeves, and half will be placebo. Participants and sleeve numbers will be randomized via REDCap.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Reparel Sleeve Group |
Reparel sleeve and corticosteroid injection |
|
|
Placebo Comparator Placebo Sleeve Group |
Placebo sleeve and corticosteroid injection |
|
Recruiting Locations
Birmingham, Alabama 35205
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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.