Knee OsteoarthritisNCT04743921
Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis
A study testing Reparel Knee Sleeve in people with Knee Osteoarthritis, 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
- Knee Osteoarthritis
- What is being tested?
- Reparel Knee Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 6 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- no corticosteroid knee injection for 90 days prior to consent
- no corticosteroid knee injection for 90 days following consent
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Reparel 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Reparel Sleeve Group | Experimental | Patients receiving reparel knee sleeve for treatment of knee osteoarthritis. Receives: Device: Reparel Knee Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Feb 2021
- Primary completion6 Nov 2021
- Study completion6 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT04743921
- Sponsor's protocol ID
- IRB-300006549
- Status last verified
- May 2024
- First submitted
- 3 Feb 2021
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reparel™ Knee Sleeve on Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04743921
- Acronym / sponsor ID
- IRB-300006549
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 6 Nov 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 16 May 2024
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reparel Sleeve Group | Experimental | Device: Reparel Knee SleevePatients receiving reparel knee sleeve for treatment of knee osteoarthritis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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 SleevePatients 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. | Device | Reparel Sleeve Group |
Primary outcome
University of California, Los Angeles (UCLA) Activity Score
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Visual Analog Scale (VAS)
Time frame: 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)
Time frame: 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 Activities of Daily Living (KOOS-ADL)
Time frame: 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.
Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL)
Time frame: 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 Sports and Recreation (KOOS-Sp)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 in people with Knee Osteoarthritis, 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 4 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 16 May 2024. 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. 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?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
University of California, Los Angeles (UCLA) Activity Score (time frame: 3 months). The study lists 10 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 16 May 2024.