Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743921
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2021-02-03
Brief Title:
Effects of Reparel Knee Sleeve on Knee Osteoarthritis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Effects of Reparel Knee Sleeve on Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 510k 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None