Effect of Reparel Knee Sleeve With Knee Injection
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reparel knee sleeve
Corticosteroid injection
Placebo knee sleeve
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- osteoarthritis visible on knee radiograph
- patient opting for non-surgical treatment
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
Sites / Locations
- UAB Hospital HighlandsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Reparel Sleeve Group
Placebo Sleeve Group
Arm Description
Reparel sleeve and corticosteroid injection
Placebo sleeve and corticosteroid injection
Outcomes
Primary Outcome Measures
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
activity score, 1-10, 10 is best outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 3 months
activity score, 1-10, 10 is best outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 6 months
activity score, 1-10, 10 is best outcome
Change in Lysholm Score at 4 weeks
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Lysholm Score at 3 months
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Lysholm Score at 6 months
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Oxford Knee Score (OKS) at 4 weeks
knee pain and function score, 0-48, 48 is best outcome
Change in Oxford Knee Score (OKS) at 3 months
knee pain and function score, 0-48, 48 is best outcome
Change in Oxford Knee Score (OKS) at 6 months
knee pain and function score, 0-48, 48 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks
knee pain and function score, 0-100, 100 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
knee pain and function score, 0-100, 100 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
knee pain and function score, 0-100, 100 is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks
function score, 0-100%, 100% is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 3 months
function score, 0-100%, 100% is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 6 months
function score, 0-100%, 100% is best outcome
Change in Visual Analog Scale (VAS) at 4 weeks
pain score, 0-10, 10 is best outcome
Change in Visual Analog Scale (VAS) at 3 months
pain score, 0-10, 10 is best outcome
Change in Visual Analog Scale (VAS) at 6 months
pain score, 0-10, 10 is best outcome
Secondary Outcome Measures
Satisfaction with knee sleeve at 4 weeks
0-10, 10 is best
Satisfaction with knee sleeve at 3 months
0-10, 10 is best
Satisfaction with knee sleeve at 6 months
0-10, 10 is best
Average wear time of sleeve over past week at 4 weeks
0-24 hours, 24 hours is best
Average wear time of sleeve over past week at 3 months
0-24 hours, 24 hours is best
Average wear time of sleeve over past week at 6 months
0-24 hours, 24 hours is best
Full Information
NCT ID
NCT04859764
First Posted
March 2, 2021
Last Updated
November 30, 2022
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04859764
Brief Title
Effect of Reparel Knee Sleeve With Knee Injection
Official Title
Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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 if the Reparel™ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo knee sleeve in managing knee OA.
Detailed Description
Patients who are recommended non-operative management of their knee osteoarthritis and have consented to participate in the study will be randomized into two groups to receive either of the following
Reparel knee sleeve
Placebo knee sleeve
Participants assigned to both groups 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.
Not to receive any injections in the subsequent 6 months following baseline randomization visit.
Participant background information that is relevant to this study will also be collected from their medical record including age, sex, and race and stored in a hospital secure computer database (REDCap).
Participants will also be asked to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), Single Assessment Numeric Evaluation (SANE), Oxford Knee Score (OKS), Lysholm Score, UCLA Activity Score and Visual Analog Scale (VAS) survey questionnaires at baseline randomization visit (T0), at 4 weeks (T1), at 3 months (T2), and at 6 months (T3) to assess the mobility, functionality, and pain associated with the affected leg.
The responses to the surveys will be recorded on a password-protected laptop and all patient identifiers will be replaced with unique identifier numbers. Only the study team will have access to the responses from the forms. The analysis of de-identified data will be done through SPSS 27, and scores for the questionnaires will be averaged and compared between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Unmarked sleeves will be used. Half will be Reparel sleeves, and half will be placebo. Participants and sleeve numbers will be randomized via REDCap.
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reparel Sleeve Group
Arm Type
Experimental
Arm Description
Reparel sleeve and corticosteroid injection
Arm Title
Placebo Sleeve Group
Arm Type
Placebo Comparator
Arm Description
Placebo sleeve and corticosteroid injection
Intervention Type
Device
Intervention Name(s)
Reparel knee sleeve
Intervention Description
Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Other Intervention Name(s)
betamethasone and bupivacaine 0.5%
Intervention Description
intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)
Intervention Type
Device
Intervention Name(s)
Placebo knee sleeve
Intervention Description
unlabeled compression knee sleeve
Primary Outcome Measure Information:
Title
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
Description
activity score, 1-10, 10 is best outcome
Time Frame
4 weeks (T1)
Title
Change in University of California, Los Angeles (UCLA) Activity Score at 3 months
Description
activity score, 1-10, 10 is best outcome
Time Frame
3 months (T2)
Title
Change in University of California, Los Angeles (UCLA) Activity Score at 6 months
Description
activity score, 1-10, 10 is best outcome
Time Frame
6 months (T3)
Title
Change in Lysholm Score at 4 weeks
Description
ability to manage activities of daily living, 0-100, 100 is best outcome
Time Frame
4 weeks (T1)
Title
Change in Lysholm Score at 3 months
Description
ability to manage activities of daily living, 0-100, 100 is best outcome
Time Frame
3 months (T2)
Title
Change in Lysholm Score at 6 months
Description
ability to manage activities of daily living, 0-100, 100 is best outcome
Time Frame
6 months (T3)
Title
Change in Oxford Knee Score (OKS) at 4 weeks
Description
knee pain and function score, 0-48, 48 is best outcome
Time Frame
4 weeks (T1)
Title
Change in Oxford Knee Score (OKS) at 3 months
Description
knee pain and function score, 0-48, 48 is best outcome
Time Frame
3 months (T2)
Title
Change in Oxford Knee Score (OKS) at 6 months
Description
knee pain and function score, 0-48, 48 is best outcome
Time Frame
6 months (T3)
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks
Description
knee pain and function score, 0-100, 100 is best outcome
Time Frame
4 weeks (T1)
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
Description
knee pain and function score, 0-100, 100 is best outcome
Time Frame
3 months (T2)
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
Description
knee pain and function score, 0-100, 100 is best outcome
Time Frame
6 months (T3)
Title
Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks
Description
function score, 0-100%, 100% is best outcome
Time Frame
4 weeks (T1)
Title
Change in Single Assessment Numeric Evaluation (SANE) at 3 months
Description
function score, 0-100%, 100% is best outcome
Time Frame
3 months (T2)
Title
Change in Single Assessment Numeric Evaluation (SANE) at 6 months
Description
function score, 0-100%, 100% is best outcome
Time Frame
6 months (T3)
Title
Change in Visual Analog Scale (VAS) at 4 weeks
Description
pain score, 0-10, 10 is best outcome
Time Frame
4 weeks (T1)
Title
Change in Visual Analog Scale (VAS) at 3 months
Description
pain score, 0-10, 10 is best outcome
Time Frame
3 months (T2)
Title
Change in Visual Analog Scale (VAS) at 6 months
Description
pain score, 0-10, 10 is best outcome
Time Frame
6 months (T3)
Secondary Outcome Measure Information:
Title
Satisfaction with knee sleeve at 4 weeks
Description
0-10, 10 is best
Time Frame
4 weeks (T1)
Title
Satisfaction with knee sleeve at 3 months
Description
0-10, 10 is best
Time Frame
3 months (T2)
Title
Satisfaction with knee sleeve at 6 months
Description
0-10, 10 is best
Time Frame
6 months (T3)
Title
Average wear time of sleeve over past week at 4 weeks
Description
0-24 hours, 24 hours is best
Time Frame
4 weeks (T1)
Title
Average wear time of sleeve over past week at 3 months
Description
0-24 hours, 24 hours is best
Time Frame
3 months (T2)
Title
Average wear time of sleeve over past week at 6 months
Description
0-24 hours, 24 hours is best
Time Frame
6 months (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
osteoarthritis visible on knee radiograph
patient opting for non-surgical treatment
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Momaya, MD
Phone
+1 (205) 975-2663
Email
amit.momaya@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Momaya, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Hospital Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Momaya, MD
Phone
205-930-8339
Email
amomaya@uabmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Reparel Knee Sleeve With Knee Injection
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