Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Reparel Knee Sleeve

• Registration Number: NCT04743921
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-08
• Primary Completion: 2021-11-06
• Study Completion: 2021-11-06
• Results First Submitted: 2024-01-29
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Results First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reparel Sleeve Group	Reparel Knee Sleeve	Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Primary Outcome Measures

Name	Time	Method
University of California, Los Angeles (UCLA) Activity Score	3 months	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.
Lysholm Score	3 months	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.
Oxford Knee Score (OKS)	3 months	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.
Knee Injury and Osteoarthritis Outcome Score Pain (KOOS-P)	3 months	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.
Single Assessment Numeric Evaluation (SANE)	3 months	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.
Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)	3 months	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.
Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS-ADL)	3 months	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.
Visual Analog Scale (VAS)	3 months	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.
Knee Injury and Osteoarthritis Outcome Score Symptoms (KOOS-Sy)	3 months	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.
Knee Injury and Osteoarthritis Outcome Score Sports and Recreation (KOOS-Sp)	3 months	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.

Trial Locations

Locations (1)

UAB Hospital Highlands; 🇺🇸 Birmingham, Alabama, United States