Knee OsteoarthritisNCT05222503
Impact of Sensor Technology in Knee OA
A study testing Knee Brace + OPUM Digital Knee and Knee Brace in people with Knee Osteoarthritis, run by OPUM Technologies US LTD at 1 site in United States.
Trial summary
OBJECTIVES: Physical activity has been established as an important component of rehabilitation for knee osteoarthritis (OA), and is often guided by a physical therapist.(1) Physical therapy for knee OA typically involves 1-3 sessions with a licensed physical therapist per week, for up to 12 weeks. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Knee Brace + OPUM Digital Knee and Knee Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 14 Jul 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain score > 12.5 KOOS
- BMI < 35
- Own a compatible mobile phone?
- Able to operate Bluetooth technology?
- Diagnosis of unilateral femoro-tibial knee OA
Who cannot join
- History of lower extremity total joint arthroplasty? (in affected knee)
- Current uncontrolled cardiovascular disease?
- Other pathology? Ex: Parkinson's, stroke, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or other knee diseases (Paget, osteonecrosis, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Rose Darcy, BS, 818-301-9213, rdarcy@sralab.org
Rose Darcy, BS
About this study
Official title: The Impact of Sensor Technology in Individuals With Knee OA
OBJECTIVES:
Physical activity has been established as an important component of rehabilitation for knee osteoarthritis (OA), and is often guided by a physical therapist.(1) Physical therapy for knee OA typically involves 1-3 sessions with a licensed physical therapist per week, for up to 12 weeks. These sessions can take a lot of time and effort for subjects, particularly when travel times are considered. Remote patient monitoring is an emerging treatment method which can help to reduce the need for in-person treatment sessions.
Read more
Remote patient monitoring has been tested in subjects after a total knee arthroplasty, and initial results show that subjects find the process motivating and engaging.(2) This process has not been tested in individuals with symptomatic knee OA. Prior studies have shown that personalized internet based programs are effective at improving function in individuals with knee OA(3), but the effectiveness of these programs with remote patient monitoring is unknown.
One example of current wearable technology that can be utilized for remote patient monitoring is the Opum (OPUM) Digital Knee® (ODK) modular orthotic. The ODK utilizes a wearable device in a knee brace which relays real time information back to the subject and physical therapist via their mobile phone. The ODK can provide information about sagittal and frontal plane knee kinematics, sagittal plane knee range of motion, time spent performing various daily activities, time spent exercising, overall load on the knee joint, and progress over time in each of these metrics. This device has been previously tested in subjects after an ACL reconstruction, but has yet to be tested in subjects with knee osteoarthritis.
The objective of this study is to assess the effect of the ODK technology in a medial knee unloader brace with remote patient monitoring on pain, function, and quality of life in individuals with knee OA. This study will contain two groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring.
The hypothesis is that subjects who wear the knee brace with the ODK with remote patient monitoring will have a greater reduction in pain and increase in quality of life than those who receive the brace with a home exercise program.
Read the detailed description
BACKGROUND:
Knee osteoarthritis (OA) is a significant problem in the adult population. With a prevalence of 10-13% in individuals over age 60,(4) knee OA results in a significant reduction in quality of life and increased economic costs to both the individual with knee OA and the medical system as a whole.
Exercise is a key component of management of knee OA, resulting in decreased pain and increased function.(3) Potential barriers to exercise in subjects with knee OA is lack of motivation or professional support.(5) Both of these barriers can be addressed with remote patient monitoring. Remote patient monitoring will allow a physical therapist to monitor the activity levels and progress of each subject, and make adjustments throughout the duration the rehab program.
Wearable technology has begun to disrupt conventional methods of healthcare delivery. Wearable technology can allow for remote patient monitoring and self monitoring for subjects with OA. The ODK is a novel wearable device which has previously been tested in subjects with anterior cruciate ligament (ACL) reconstructions, but has not yet been tested in individuals with knee OA. The ODK allows for tracking of knee range of motion, frontal plane kinematics, sagittal plane kinematics, exercise progress, time spent walking/standing/sitting/kneeling, and time spent sedentary. These measures can help to provide useful information to the patient on potential mitigating factors in their knee OA and provide real time feedback about joint kinematics.
This study will investigate the effects of the ODK used in a medial off-loader brace with remote patient monitoring. This randomized control trial will have 2 groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring. These subjects will be followed for 12 weeks and assessed for changes in pain, function, and quality of life.
- Conditions
- Knee Osteoarthritis
- Being tested
- Knee Brace + OPUM Digital Knee, Knee Brace
- Keywords
- osteoarthritis, knee, orthotics, remote patient monitoring, wearable technology, brace
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Brace + OPUM Digital KneeDevice
Knee Brace + OPUM Digital Knee
Knee BraceDevice
Knee Brace without OPUM Digital Knee
| Study group | Role | What they receive |
|---|---|---|
| Control group: Medial off-loader brace and home exercise program | Active comparator | The subject will receive a traditional medial off-loader brace and a take-home, self-guided exercise program. The subject will be instructed how to wear the brace. The subject will be instructed to incrementally increase wear time of the brace in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week. Receives: Device: Knee Brace |
| 2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient Monitoring | Experimental | The same off-loader brace as above but with the ODK sensor will be provided. The subject will be instructed how to wear the brace and sensor. The patient will be instructed to incrementally increase wear time in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week. Using the sensor they will be able to keep track of their exercise frequency, range of motion (ROM), and kinematics in the OPUM app on their mobile phone. Education/resources will also be provided to the subjects via modules in the mobile app. The subjects will be instructed how to use the app as well.
Patients data will be monitored remotely for 20mins per patient per month in the sensor group. Programs will be updated as necessary based on data. Receives: Device: Knee Brace + OPUM Digital Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Measured by the Knee injury and osteoarthritis score subscale (KOOS subscales) as a comparison between both groups of the evolution of pain between Day 0 and Week 12.
Measured: 12 weeks from onset of brace wearing
Secondary outcomes (14)
Symptoms
Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales) as a comparison between day 0 and week 12.
Measured: 12 weeks from onset of brace wearing
Function
Measured by the Function Knee injury and osteoarthritis score subscales (KOOS subscales) as a comparison between day 0 and week 12.
Measured: 12 weeks from onset of brace wearing
Impact of Osteoarthritis on Quality of Life
Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales) as a comparison between day 0 and week 12.
Measured: 12 weeks from onset of brace wearing
Quality of life measured using the EQ5D survey
Measured via the EQ5D survey as a comparison from day 0 and week 12.
Measured: 12 weeks from onset of brace wearing
Walking speed
Measured using the 10 m walk test: participants are timed as they walk 10m and this walking speed is calculated using (speed = distance/time) in m/s. Done on day 0 and compared to week 12
Measured: 12 weeks from onset of brace wearing
Walking endurance
Measured using 6min walk test: participant walks for 6 minutes and the distance (m) walked is measured. If needed, the number of breaks taken is noted. Test done on day 0 and compared to week 12
Measured: 12 weeks from onset of brace wearing
Stair negotiation
Participants are timed (seconds) as they ascend and descend a flight of stairs. Done on day 0 and after 12 weeks of brace wearing; times are compared.
Measured: 12 weeks from onset of brace wearing
5 times sit-to-stand
Participants are timed (seconds) as they stand from a seated position in a chair and sit back down 5 times. This exercise is timed on day 0 and after 12 weeks of brace wearing; times are compared.
Measured: 12 weeks from onset of brace wearing
Patient diary
Self-reported compliance with brace wearing and exercise program
Measured: 12 weeks
Digital Knee Data (for intervention group)
Activity recorded by the ODK module for the intervention group during the 12 week intervention
Measured: 12 weeks
Patient satisfaction
Survey administered after the 12 week intervention that assessed patient satisfaction using questions about likelihood of having surgical treatment in the 12 months that followed the study.
One question asked if patients were A. More Likely, B. Less Likely, C. Unchanged Another question asked patients to indicate on a scale of 0-100, how likely they were to get surgery where 0=unlikely and 100=very likely.
Another question that asked whether or not patients would continue to use the program after completion of the study time period.
Measured: At 12-week follow-up visit
System Usability Scale (for intervention group)
A survey administered to get feedback on the user-friendliness of the device and application. With an optional space for additional feedback. Participants' impression of the program are assessed by presenting multiple sentences such as "I found this device easy to use" and asking the participant to rank the statement on a scale of 1 to 5, where 1 = strongly disagree and 5 = strongly agree.
Measured: At 12-week follow-up visit
Condition Improvement
Survey questions addressing perceived change in condition by asking patients to (one question): describe the change in ACTIVITY, LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE associated with your osteoarthritis condition.
The answer choices were:
- No change (Or condition has gotten worse) B. Almost the same, hardly any change at all C. A little better, but no noticeable change D. Somewhat better, but the change has not made any real difference E. Moderately better, and a slight but noticeable change F. Better and a definite improvement that has made a real and worthwhile difference G. A great deal better and a considerable improvement that has made all the difference
Another survey question addressing perceived change in condition by indicating their improvement on a scale of 0-100 where 0 = very much worse, 50 = unchanged, and 100 = very much better.
Measured: At 12-week follow-up visit
Need for medication to treat osteoarthritis symptoms
Assessed in the form of a survey question that asked participants to describe the amount of medication they take for their osteoarthritis since the onset of the study.
The answer choices were: UNCHANGED, STOPPED, DECREASED, INCREASED, N/A
Measured: At 12-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start19 Aug 2021
- Primary completion31 May 2022 (estimated)
- Study completion14 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OPUM Technologies US LTD
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Sponsor
- Investigators
- Prakash Jayabalan, MD, PhD, Principal investigator, Shirley Ryan AbilityLab; Northwestern University Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222503
- Sponsor's protocol ID
- STU00214887
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PubMed 20699159Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.
PubMed 23559821Ramkumar PN, Haeberle HS, Ramanathan D, Cantrell WA, Navarro SM, Mont MA, Bloomfield M, Patterson BM. Remote Patient Monitoring Using Mobile Health for Total Knee Arthroplasty: Validation of a Wearable and Machine Learning-Based Surveillance Platform. J Arthroplasty. 2019 Oct;34(10):2253-2259. doi: 10.1016/j.arth.2019.05.021. Epub 2019 May 16.
PubMed 31128890Bosomworth NJ. Exercise and knee osteoarthritis: benefit or hazard? Can Fam Physician. 2009 Sep;55(9):871-8.
PubMed 19752252Kanavaki AM, Rushton A, Efstathiou N, Alrushud A, Klocke R, Abhishek A, Duda JL. Barriers and facilitators of physical activity in knee and hip osteoarthritis: a systematic review of qualitative evidence. BMJ Open. 2017 Dec 26;7(12):e017042. doi: 10.1136/bmjopen-2017-017042.
PubMed 29282257
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sensor Technology in Individuals With Knee OA
- ClinicalTrials.gov ID
- NCT05222503
- Acronym / sponsor ID
- STU00214887
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, knee, orthotics, remote patient monitoring, wearable technology, brace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- OPUM Technologies US LTDUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 14 Jul 2022 (estimated)
- First posted
- 3 Feb 2022 (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.
OBJECTIVES:
Physical activity has been established as an important component of rehabilitation for knee osteoarthritis (OA), and is often guided by a physical therapist.(1) Physical therapy for knee OA typically involves 1-3 sessions with a licensed physical therapist per week, for up to 12 weeks. These sessions can take a lot of time and effort for subjects, particularly when travel times are considered. Remote patient monitoring is an emerging treatment method which can help to reduce the need for in-person treatment sessions.
Remote patient monitoring has been tested in subjects after a total knee arthroplasty, and initial results show that subjects find the process motivating and engaging.(2) This process has not been tested in individuals with symptomatic knee OA. Prior studies have shown that personalized internet based programs are effective at improving function in individuals with knee OA(3), but the effectiveness of these programs with remote patient monitoring is unknown.
One example of current wearable technology that can be utilized for remote patient monitoring is the Opum (OPUM) Digital Knee® (ODK) modular orthotic. The ODK utilizes a wearable device in a knee brace which relays real time information back to the subject and physical therapist via their mobile phone. The ODK can provide information about sagittal and frontal plane knee kinematics, sagittal plane knee range of motion, time spent performing various daily activities, time spent exercising, overall load on the knee joint, and progress over time in each of these metrics. This device has been previously tested in subjects after an ACL reconstruction, but has yet to be tested in subjects with knee osteoarthritis.
The objective of this study is to assess the effect of the ODK technology in a medial knee unloader brace with remote patient monitoring on pain, function, and quality of life in individuals with knee OA. This study will contain two groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring.
The hypothesis is that subjects who wear the knee brace with the ODK with remote patient monitoring will have a greater reduction in pain and increase in quality of life than those who receive the brace with a home exercise program.
Detailed description
BACKGROUND:
Knee osteoarthritis (OA) is a significant problem in the adult population. With a prevalence of 10-13% in individuals over age 60,(4) knee OA results in a significant reduction in quality of life and increased economic costs to both the individual with knee OA and the medical system as a whole.
Exercise is a key component of management of knee OA, resulting in decreased pain and increased function.(3) Potential barriers to exercise in subjects with knee OA is lack of motivation or professional support.(5) Both of these barriers can be addressed with remote patient monitoring. Remote patient monitoring will allow a physical therapist to monitor the activity levels and progress of each subject, and make adjustments throughout the duration the rehab program.
Wearable technology has begun to disrupt conventional methods of healthcare delivery. Wearable technology can allow for remote patient monitoring and self monitoring for subjects with OA. The ODK is a novel wearable device which has previously been tested in subjects with anterior cruciate ligament (ACL) reconstructions, but has not yet been tested in individuals with knee OA. The ODK allows for tracking of knee range of motion, frontal plane kinematics, sagittal plane kinematics, exercise progress, time spent walking/standing/sitting/kneeling, and time spent sedentary. These measures can help to provide useful information to the patient on potential mitigating factors in their knee OA and provide real time feedback about joint kinematics.
This study will investigate the effects of the ODK used in a medial off-loader brace with remote patient monitoring. This randomized control trial will have 2 groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring. These subjects will be followed for 12 weeks and assessed for changes in pain, function, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: Medial off-loader brace and home exercise program | Active comparator | Device: Knee BraceThe subject will receive a traditional medial off-loader brace and a take-home, self-guided exercise program. The subject will be instructed how to wear the brace. The subject will be instructed to incrementally increase wear time of the brace in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week. |
| 2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient Monitoring | Experimental | Device: Knee Brace + OPUM Digital KneeThe same off-loader brace as above but with the ODK sensor will be provided. The subject will be instructed how to wear the brace and sensor. The patient will be instructed to incrementally increase wear time in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week. Using the sensor they will be able to keep track of their exercise frequency, range of motion (ROM), and kinematics in the OPUM app on their mobile phone. Education/resources will also be provided to the subjects via modules in the mobile app. The subjects will be instructed how to use the app as well. Patients data will be monitored remotely for 20mins per patient per month in the sensor group. Programs will be updated as necessary based on data. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain score > 12.5 KOOS
- BMI < 35
- Own a compatible mobile phone?
- Able to operate Bluetooth technology?
- Diagnosis of unilateral femoro-tibial knee OA
Key exclusion criteria (3 listed)
- History of lower extremity total joint arthroplasty? (in affected knee)
- Current uncontrolled cardiovascular disease?
- Other pathology? Ex: Parkinson's, stroke, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or other knee diseases (Paget, osteonecrosis, etc.)
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 |
|---|---|---|
| Knee Brace + OPUM Digital KneeKnee Brace + OPUM Digital Knee | Device | 2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient Monitoring |
| Knee BraceKnee Brace without OPUM Digital Knee | Device | Control group: Medial off-loader brace and home exercise program |
Primary outcome
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Time frame: 12 weeks from onset of brace wearing
Measured by the Knee injury and osteoarthritis score subscale (KOOS subscales) as a comparison between both groups of the evolution of pain between Day 0 and Week 12.
14 secondary outcomes
Symptoms
Time frame: 12 weeks from onset of brace wearing
Function
Time frame: 12 weeks from onset of brace wearing
Impact of Osteoarthritis on Quality of Life
Time frame: 12 weeks from onset of brace wearing
Quality of life measured using the EQ5D survey
Time frame: 12 weeks from onset of brace wearing
Walking speed
Time frame: 12 weeks from onset of brace wearing
Walking endurance
Time frame: 12 weeks from onset of brace wearing
Stair negotiation
Time frame: 12 weeks from onset of brace wearing
5 times sit-to-stand
Time frame: 12 weeks from onset of brace wearing
Patient diary
Time frame: 12 weeks
Digital Knee Data (for intervention group)
Time frame: 12 weeks
Patient satisfaction
Time frame: At 12-week follow-up visit
System Usability Scale (for intervention group)
Time frame: At 12-week follow-up visit
Condition Improvement
Time frame: At 12-week follow-up visit
Need for medication to treat osteoarthritis symptoms
Time frame: At 12-week follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 20699159Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
- Results publication: PubMed 23559821Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.
- Results publication: PubMed 31128890Ramkumar PN, Haeberle HS, Ramanathan D, Cantrell WA, Navarro SM, Mont MA, Bloomfield M, Patterson BM. Remote Patient Monitoring Using Mobile Health for Total Knee Arthroplasty: Validation of a Wearable and Machine Learning-Based Surveillance Platform. J Arthroplasty. 2019 Oct;34(10):2253-2259. doi: 10.1016/j.arth.2019.05.021. Epub 2019 May 16.
- Results publication: PubMed 19752252Bosomworth NJ. Exercise and knee osteoarthritis: benefit or hazard? Can Fam Physician. 2009 Sep;55(9):871-8.
- Results publication: PubMed 29282257Kanavaki AM, Rushton A, Efstathiou N, Alrushud A, Klocke R, Abhishek A, Duda JL. Barriers and facilitators of physical activity in knee and hip osteoarthritis: a systematic review of qualitative evidence. BMJ Open. 2017 Dec 26;7(12):e017042. doi: 10.1136/bmjopen-2017-017042.
- 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.
Prakash Jayabalan, MD, PhD principal investigator
Shirley Ryan AbilityLab; Northwestern University Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Brace + OPUM Digital Knee and Knee Brace in people with Knee Osteoarthritis, run by OPUM Technologies US LTD 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rose Darcy, BS (818-301-9213, rdarcy@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey) (time frame: 12 weeks from onset of brace wearing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05222503, which also lists 5 linked publications.
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 3 Feb 2022.