N/A
N=14
Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04743921 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: University of California, Los Angeles (UCLA) Activity Score — 5.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reparel Knee Sleeve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY University of California, Los Angeles (UCLA) Activity Score |
5.4 | — |
| PRIMARY Lysholm Score |
75.0 | — |
| PRIMARY Oxford Knee Score (OKS) |
38.2 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P) |
72.9 | — |
| PRIMARY Single Assessment Numeric Evaluation (SANE) |
72.0 | — |
| PRIMARY Visual Analog Scale (VAS) |
3.0 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy) |
75.6 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL) |
81.37 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) |
59.9 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp) |
47.5 | — |
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 the clinical effects of Reparel™ knee sleeve regarding mobility, functionality, and pain outcomes in managing knee OA.
Eligibility Criteria
Inclusion Criteria
- osteoarthritis visible on knee radiograph
- patient opting for non-surgical treatment
- no corticosteroid knee injection for 90 days prior to consent
- no corticosteroid knee injection for 90 days following consent
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
Data sourced from ClinicalTrials.gov (NCT04743921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.