Knee OsteoarthritisERGONOMIENCT02765685
Internal Compartment Knee Osteoarthritis: ODRA (Orthosis Distraction and Rotation for osteoArthritis) Made-to-measure Hinged Knee Brace Versus Usual Care.
A study testing brace ODRA (PROTEOR company) in people with Knee Osteoarthritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups: 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- brace ODRA (PROTEOR company)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Knee osteoarthritis (defined according to American College of Reumatology criteria):
- radiological stage II, III or IV according to the Kellgren and Lawrence (KL) classification documented by a radiological examination in the previous 12 months.
- Predominantly affecting the internal compartment (internal KL stage greater than external KL stage) and symptomatic with a Pain Visual Analogue Scale > 40/100 on the target side (side with the most symptomatic disease)
- Patients who have provided written consent
- Patients able to understand simple instructions, to read, write, and to give informed consent
- Patients with national health insurance cover
Who cannot join
- Severe venous insufficiency in the lower limbs
- History of deep venous thrombosis in the lower limbs
- Inflammatory flare of knee osteoarthritis (synovial effusion) on the target side
- Person over 18 under guardianship or unable to provide consent
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:
- 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.
- 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.
The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- brace ODRA (PROTEOR company), Usual care
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brace ODRA (PROTEOR company)Device
Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position.
Usual careOther
The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the "usual" said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers.
| Study group | Role | What they receive |
|---|---|---|
| ODRA | Experimental | Not described Receives: Device: brace ODRA (PROTEOR company); Other: Usual care |
| usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured using a VAS (visual analogue scale) by the patient
Measured: 12 months
Secondary outcomes (8)
Ratio differential cost-utility
Measured: 12 months
Evolution of pain measured by VAS in the form of a self-questionnaire
Measured: 6 months
Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire
Measured: 12 months
Evolution of quality of life measured by the AMIQUAL self-questionnaire
Measured: 12 months
Evolution de overall disease activity measured by VAS
Measured: 12 months
Consumption of care relative to the knee osteoarthritis
Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support
Measured: 12 months
Local or general adverse effects
Measured: 12 months
Compliance with wearing the brace
Average number of hours of port of the brace a day, the average number of days of port of the brace a week. The possible motives for non-observance will be brought together.
The patient will be considered compliant if he carries his brace at least 15 hours a week on average.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765685
- Sponsor's protocol ID
- ORNETTI 2013
- Acronym
- ERGONOMIE
- Status last verified
- Aug 2018
- First submitted
- 29 Apr 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial in Internal Compartment Knee Osteoarthritis: ODRA Made-to-measure Hinged Knee Brace Versus Usual Care.
- ClinicalTrials.gov ID
- NCT02765685
- Acronym / sponsor ID
- ERGONOMIE / ORNETTI 2013
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- First posted
- 9 May 2016 (estimated)
- 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.
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:
- 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months.
- 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down.
The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODRA | Experimental | Device: brace ODRA (PROTEOR company), Other: Usual care |
| usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- Knee osteoarthritis (defined according to American College of Reumatology criteria):
- Patients who have provided written consent
- Patients able to understand simple instructions, to read, write, and to give informed consent
- Patients with national health insurance cover
Key exclusion criteria (5 listed)
- Severe venous insufficiency in the lower limbs
- History of deep venous thrombosis in the lower limbs
- Inflammatory flare of knee osteoarthritis (synovial effusion) on the target side
- Person over 18 under guardianship or unable to provide consent
- Pregnant or breast-feeding women
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 |
|---|---|---|
| brace ODRA (PROTEOR company)Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position. | Device | ODRA |
| Usual careThe patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the "usual" said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers. | Other | ODRA, usual care |
Primary outcome
Pain measured using a VAS (visual analogue scale) by the patient
Time frame: 12 months
8 secondary outcomes
Ratio differential cost-utility
Time frame: 12 months
Evolution of pain measured by VAS in the form of a self-questionnaire
Time frame: 6 months
Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire
Time frame: 12 months
Evolution of quality of life measured by the AMIQUAL self-questionnaire
Time frame: 12 months
Evolution de overall disease activity measured by VAS
Time frame: 12 months
Consumption of care relative to the knee osteoarthritis
Time frame: 12 months
Local or general adverse effects
Time frame: 12 months
Compliance with wearing the brace
Time frame: 12 months
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 22 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brace ODRA (PROTEOR company) in people with Knee Osteoarthritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 7 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 22 Aug 2018. 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 France. 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?
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?
Pain measured using a VAS (visual analogue scale) by the patient (time frame: 12 months). 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 22 Aug 2018.