Osteoarthritis, KneeNCT04859764
Effect of Reparel Knee Sleeve With Knee Injection
A study testing Reparel knee sleeve and Corticosteroid injection in people with Osteoarthritis, Knee, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Reparel knee sleeve and Corticosteroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis visible on knee radiograph
- patient opting for non-surgical treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Reparel knee sleeve, Corticosteroid injection, Placebo knee sleeve
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reparel knee sleeveDevice
Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain
Corticosteroid injectionDrug
Also called betamethasone and bupivacaine 0.5%
intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)
Placebo knee sleeveDevice
unlabeled compression knee sleeve
| Study group | Role | What they receive |
|---|---|---|
| Reparel Sleeve Group | Experimental | Reparel sleeve and corticosteroid injection Receives: Device: Reparel knee sleeve; Drug: Corticosteroid injection |
| Placebo Sleeve Group | Placebo comparator | Placebo sleeve and corticosteroid injection Receives: Drug: Corticosteroid injection; Device: Placebo knee sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
activity score, 1-10, 10 is best outcome
Measured: 4 weeks (T1)
Change in University of California, Los Angeles (UCLA) Activity Score at 3 months
activity score, 1-10, 10 is best outcome
Measured: 3 months (T2)
Change in University of California, Los Angeles (UCLA) Activity Score at 6 months
activity score, 1-10, 10 is best outcome
Measured: 6 months (T3)
Change in Lysholm Score at 4 weeks
ability to manage activities of daily living, 0-100, 100 is best outcome
Measured: 4 weeks (T1)
Change in Lysholm Score at 3 months
ability to manage activities of daily living, 0-100, 100 is best outcome
Measured: 3 months (T2)
Change in Lysholm Score at 6 months
ability to manage activities of daily living, 0-100, 100 is best outcome
Measured: 6 months (T3)
Change in Oxford Knee Score (OKS) at 4 weeks
knee pain and function score, 0-48, 48 is best outcome
Measured: 4 weeks (T1)
Change in Oxford Knee Score (OKS) at 3 months
knee pain and function score, 0-48, 48 is best outcome
Measured: 3 months (T2)
Change in Oxford Knee Score (OKS) at 6 months
knee pain and function score, 0-48, 48 is best outcome
Measured: 6 months (T3)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks
knee pain and function score, 0-100, 100 is best outcome
Measured: 4 weeks (T1)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
knee pain and function score, 0-100, 100 is best outcome
Measured: 3 months (T2)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
knee pain and function score, 0-100, 100 is best outcome
Measured: 6 months (T3)
Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks
function score, 0-100%, 100% is best outcome
Measured: 4 weeks (T1)
Change in Single Assessment Numeric Evaluation (SANE) at 3 months
function score, 0-100%, 100% is best outcome
Measured: 3 months (T2)
Change in Single Assessment Numeric Evaluation (SANE) at 6 months
function score, 0-100%, 100% is best outcome
Measured: 6 months (T3)
Need for Additional CSI
need for additional CSI after baseline injection
Measured: 6 months
Change in Visual Analog Scale (VAS) at 4 weeks
pain score, 0-10, 10 is best outcome
Measured: 4 weeks (T1)
Change in Visual Analog Scale (VAS) at 3 months
pain score, 0-10, 10 is best outcome
Measured: 3 months (T2)
Change in Visual Analog Scale (VAS) at 6 months
pain score, 0-10, 10 is best outcome
Measured: 6 months (T3)
Secondary outcomes (6)
Satisfaction with knee sleeve at 4 weeks
0-10, 10 is best
Measured: 4 weeks (T1)
Satisfaction with knee sleeve at 3 months
0-10, 10 is best
Measured: 3 months (T2)
Satisfaction with knee sleeve at 6 months
0-10, 10 is best
Measured: 6 months (T3)
Average wear time of sleeve over past week at 4 weeks
0-24 hours, 24 hours is best
Measured: 4 weeks (T1)
Average wear time of sleeve over past week at 3 months
0-24 hours, 24 hours is best
Measured: 3 months (T2)
Average wear time of sleeve over past week at 6 months
0-24 hours, 24 hours is best
Measured: 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start29 Jun 2022
- Primary completion1 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit Momaya, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859764
- Sponsor's protocol ID
- IRB-300006118
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04859764
- Acronym / sponsor ID
- IRB-300006118
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reparel Sleeve Group | Experimental | Device: Reparel knee sleeve, Drug: Corticosteroid injectionReparel sleeve and corticosteroid injection |
| Placebo Sleeve Group | Placebo comparator | Drug: Corticosteroid injection, Device: Placebo knee sleevePlacebo sleeve and corticosteroid injection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteoarthritis visible on knee radiograph
- patient opting for non-surgical treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reparel knee sleeveUnlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain | Device | Reparel Sleeve Group |
| Corticosteroid injectionAlso: betamethasone and bupivacaine 0.5%intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size) | Drug | Placebo Sleeve Group, Reparel Sleeve Group |
| Placebo knee sleeveunlabeled compression knee sleeve | Device | Placebo Sleeve Group |
Primary outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
Time frame: 4 weeks (T1)
activity score, 1-10, 10 is best outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 3 months
Time frame: 3 months (T2)
activity score, 1-10, 10 is best outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 6 months
Time frame: 6 months (T3)
activity score, 1-10, 10 is best outcome
Change in Lysholm Score at 4 weeks
Time frame: 4 weeks (T1)
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Lysholm Score at 3 months
Time frame: 3 months (T2)
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Lysholm Score at 6 months
Time frame: 6 months (T3)
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Oxford Knee Score (OKS) at 4 weeks
Time frame: 4 weeks (T1)
knee pain and function score, 0-48, 48 is best outcome
Change in Oxford Knee Score (OKS) at 3 months
Time frame: 3 months (T2)
knee pain and function score, 0-48, 48 is best outcome
Change in Oxford Knee Score (OKS) at 6 months
Time frame: 6 months (T3)
knee pain and function score, 0-48, 48 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks
Time frame: 4 weeks (T1)
knee pain and function score, 0-100, 100 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
Time frame: 3 months (T2)
knee pain and function score, 0-100, 100 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
Time frame: 6 months (T3)
knee pain and function score, 0-100, 100 is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks
Time frame: 4 weeks (T1)
function score, 0-100%, 100% is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 3 months
Time frame: 3 months (T2)
function score, 0-100%, 100% is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 6 months
Time frame: 6 months (T3)
function score, 0-100%, 100% is best outcome
Need for Additional CSI
Time frame: 6 months
need for additional CSI after baseline injection
Change in Visual Analog Scale (VAS) at 4 weeks
Time frame: 4 weeks (T1)
pain score, 0-10, 10 is best outcome
Change in Visual Analog Scale (VAS) at 3 months
Time frame: 3 months (T2)
pain score, 0-10, 10 is best outcome
Change in Visual Analog Scale (VAS) at 6 months
Time frame: 6 months (T3)
pain score, 0-10, 10 is best outcome
6 secondary outcomes
Satisfaction with knee sleeve at 4 weeks
Time frame: 4 weeks (T1)
Satisfaction with knee sleeve at 3 months
Time frame: 3 months (T2)
Satisfaction with knee sleeve at 6 months
Time frame: 6 months (T3)
Average wear time of sleeve over past week at 4 weeks
Time frame: 4 weeks (T1)
Average wear time of sleeve over past week at 3 months
Time frame: 3 months (T2)
Average wear time of sleeve over past week at 6 months
Time frame: 6 months (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Momaya, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reparel knee sleeve and Corticosteroid injection in people with Osteoarthritis, Knee, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks (time frame: 4 weeks (T1)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.