Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis

NCT04743921 | Completed Results FDA Device

• 1 other identifier: IRB-300006549
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Reparel Sleeve Group

EXPERIMENTAL

Patients receiving reparel knee sleeve for treatment of knee osteoarthritis.

Device: Reparel Knee Sleeve

Interventions

Reparel Knee Sleeve DEVICE

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.

Reparel Sleeve Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Amit Momaya
• Organization: University of Alabama at Birmingham Department of Orthopaedic Surgery

amomaya@uabmc.edu

205-975-2663

Study Officials

• Amit Momaya, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Section Chief, Sports Medicine

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: February 1, 2021
• Primary Completion: November 6, 2021
• Study Completion: November 6, 2021
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)