Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Reparel Knee Sleeve

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Hospital Highlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Reparel Sleeve Group; Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Device: Reparel Knee Sleeve; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
University of California, Los Angeles (UCLA) Activity Score	This is a questionnaire that measures current activity level. Patients self report their current activity level. It ranges from 1-10. A patient scoring themselves as a 1 is the lowest current activity level and represents someone who is wholly inactive. A patient scoring themselves as a 10 is the highest current activity level and represents someone able to regularly participate in impact sports.	3 months
Lysholm Score	This is a questionnaire that is self-reported by the patient. It is meant to measure a patient's ability to manage activities of daily living as it relates to their knee. The score range is from 0 to 100. A score of 0 is the lowest score associated with lower ability to manage activities of daily living, and a score of 100 is the highest score associated with a higher ability to manage activities of daily living.	3 months
Oxford Knee Score (OKS)	This is a questionnaire that is self-reported by the patient. It measures knee pain and function. It is scored from 0 to 48. A score of 0 represents the lowest score and is associated with higher knee pain and lower function. A score of 48 represents lower knee pain and higher function.	3 months
Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P)	This is a patient questionnaire that is self-reported. It is a measure of how much pain a patient has during different activities. A score of 100 represents the lowest level of pain with different activities. A score of 0 represents the highest amount of pain with different activities.	3 months
Single Assessment Numeric Evaluation (SANE)	This is a patient questionnaire that is self-reported by the patient. It represents a patient's perceived functional level of their affected joint as a percentage of normal. The score is ranged from 0% to 100%. A score of 100% is the best outcome with the patient perceiving their functional level as 100% of normal.	3 months
Visual Analog Scale (VAS)	This is a patient questionnaire that is self-reported by the patient. It measures how much knee pain the patient is having. The score ranges from 0 to 10. A score of 0 represents the best outcome with the least amount of pain. A score of 10 is the worst outcome with the most amount of pain.	3 months
Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy)	This is a patient questionnaire that is self-reported. It represents the amount of knee symptoms a patient has. A score of 0 represents the worst outcome with a patient reporting the most symptoms. A score of 100 represents the best outcome with patients reporting the least symptoms.	3 months
Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL)	This is a patient questionnaire that is self-reported by the patient. It measures the ability of a patient to perform activities of daily living as it relates to a patient's knee. A score of 0 represents the worst outcome with patients reporting the most difficulty performing activities of daily living. A score of 100 represents the best outcome with patients reporting the least difficulty with performing activities of daily living.	3 months
Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)	This is a patient questionnaire that is self-reported by the patient. It measures a patient's quality of life as it relates to their knee. A score of 0 represents the lowest quality of life as it relates to a patient's knee. A score of 100 represents the highest quality of life as it relates to a patient's knee.	3 months
Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp)	This is a patient questionnaire that is self-reported by the patient. It measures a patient's ability to perform sports and recreation as it relates to their knee. A score of 0 represents the lowest ability to perform sports and recreation as it relates to their knee. A score of 100 represents the highest ability to perform sports and recreation as it relates to their knee.	3 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Amit Momaya, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): November 6, 2021
• Study Completion (Actual): November 6, 2021

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRB-300006549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No