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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.
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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reparel Sleeve Group | Experimental | Reparel sleeve and corticosteroid injection |
|
| Placebo Sleeve Group | Placebo Comparator | Placebo sleeve and corticosteroid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reparel knee sleeve | Device | Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Momaya, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital Highlands | Birmingham | Alabama | 35205 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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Unmarked sleeves will be used. Half will be Reparel sleeves, and half will be placebo. Participants and sleeve numbers will be randomized via REDCap.
| Corticosteroid injection | Drug | intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size) |
|
|
| Placebo knee sleeve | Device | unlabeled compression knee sleeve |
|
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) |
| Need for Additional CSI | need for additional CSI after baseline injection | 6 months |
| 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) |
| 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) |
| D012216 |
| Rheumatic Diseases |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |