Eﬀects of Reparel™ Knee Sleeve on Knee Osteoarthritis

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Standard knee compression sleeves have been described throughout literature to provide beneﬁts in pain and functional outcomes through support of the ligamentous structures. Bracing is both an eﬀective and economical treatment for osteoarthritis and serves as a crucial option in the treatment of knee OA to aid in both delaying surgery and as options for young patients, or patients that are not ideal surgical candidates. Although knee sleeves are commonly utilized treatment modalities, there is a signiﬁcant paucity of literature on the eﬀects of thermo-active braces in the treatment of knee OA. This investigation will examine this non-operative treatment modality and study it eﬀect for the treatment of knee OA specifically by investigating the Reparel Knee Sleeve. The Reparel Knee Sleeve is a Class I Medical Device (510(k) exempt) and used in general sports medicine practice for the alleviation of knee pain. The authors expect that the Reparel thermos-active knee sleeve will have a signiﬁcant eﬀect on pain relief from knee OA.

Official Title
-----------------
Eﬀects of Reparel™ Knee Sleeve on Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Reparel Knee Sleeve


Participation Criteria
=================
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reparel Sleeve Group<br>Patients receiving reparel knee sleeve for treatment of knee osteoarthritis. | Device: Reparel Knee Sleeve<br>* Patients who are recommended for non-operative management of knee osteoarthritis and have been consented in clinic to participate in the study will be given a Reparel™ knee sleeve to wear for knee osteoarthritis management. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Reparel™ knee sleeve, patients 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; refrain from altering treatment for knee osteoarthritis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of California, Los Angeles (UCLA) Activity Score | activity score, 1-10, 10 is best outcome | 3 months | 
| Lysholm Score | ability to manage activities of daily living, 0-100, 100 is best outcome | 3 months | 
| Oxford Knee Score (OKS) | knee pain and function score, 0-48, 48 is best outcome | 3 months | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | knee pain and function score, 0-100, 100 is best outcome | 3 months | 
| Single Assessment Numeric Evaluation (SANE) | function score, 0-100%, 100% is best outcome | 3 months | 
| Visual Analog Scale (VAS) | pain score, 0-10, 10 is best outcome | 3 months |