Clinical trial NCT04743921: Eﬀects of Reparel™ Knee Sleeve on Knee Osteoarthritis
Official title: Eﬀects of Reparel™ Knee Sleeve on Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: University of California, Los Angeles (UCLA) Activity Score
timeFrame: 3 months
measure: Lysholm Score
timeFrame: 3 months
measure: Oxford Knee Score (OKS)
timeFrame: 3 months
measure: Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P)
timeFrame: 3 months
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: 3 months
measure: Visual Analog Scale (VAS)
timeFrame: 3 months
measure: Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy)
timeFrame: 3 months
measure: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL)
timeFrame: 3 months
measure: Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)
timeFrame: 3 months
measure: Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amit Momaya, MD
role: PRINCIPAL_INVESTIGATOR
References: