Osteoarthritis, KneePhase 3ROTORNCT02021136
Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis
A Phase 3 study testing Rebel Reliever in people with Osteoarthritis, Knee, run by Thuasne at 1 site in France.
Trial summary
The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Rebel Reliever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Sep 2016
- Phase
- Phase 3
- 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
Main Inclusion Criteria:
- Male or female over 18 years
- BMI < or egal to 35kg/m2
- symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
- diagnosis of medial femoro-tibial knee osteoarthrosis
- patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
Main Exclusion Criteria:
- femoro-patellar predominant arthrosis
- septic arthritis
- metabolic arthropathies
- chronical rheumatismal diseases
- other knee diseases
- symptomatic coxarthrosis
- controlateral gonathrosis with corticoids injections
- any other serious disease which may interfere with the results
- psychiatrics disorders
- skin lesions or dermal pathologies
- venous or arterial disorders
- sensitivity disorders in the lower limbs (diabetes mellitus..)
- paracetamol intolerance
- hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
- on going knee viscosupplementation at inclusion
- slow acting OA drugs (if started in the last 2 months prior to inclusion)
- opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
- pregnant women of with no contraception
- hepatic or renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.
The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.
Read the detailed description
The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion.
The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49).
The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Rebel Reliever, Control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebel RelieverDevice
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
ControlOther
Usual antalgic treatment + physical exercises recommendations
| Study group | Role | What they receive |
|---|---|---|
| Rebel reliever | Experimental | Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations. Receives: Device: Rebel Reliever |
| Control | Active comparator | usual antalgic treatment + physical exercises recommendations. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the last 24 hours knee pain (VAS)
Measured: Between Day 49 and Day 0
Secondary outcomes (3)
Evolution of knee pain on movement (VAS)
Evaluation with Visual Analysis Scale
Measured: Between Day 49 and Day 0
Evolution of Lequesne Algofunctional index score
Measured: Between D49 and Day 0
Responder rate according to OARSI-OMERACT criteria
Measured: At Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionSep 2016
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe THOUMIE, MD, Principal investigator, Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021136
- Sponsor's protocol ID
- 2013-A00613-42
- Other IDs
- 2013-A00613-42
- Acronym
- ROTOR
- Status last verified
- Dec 2016
- First submitted
- 14 Oct 2013
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.
- ClinicalTrials.gov ID
- NCT02021136
- Acronym / sponsor ID
- ROTOR / 2013-A00613-42
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Dec 2013 (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.
The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.
Detailed description
The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion.
The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49).
The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebel reliever | Experimental | Device: Rebel RelieverRebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations. |
| Control | Active comparator | Other: Controlusual antalgic treatment + physical exercises recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Rebel RelieverRebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations | Device | Rebel reliever |
| ControlUsual antalgic treatment + physical exercises recommendations | Other | Control |
Primary outcome
Evolution of the last 24 hours knee pain (VAS)
Time frame: Between Day 49 and Day 0
3 secondary outcomes
Evolution of knee pain on movement (VAS)
Time frame: Between Day 49 and Day 0
Evolution of Lequesne Algofunctional index score
Time frame: Between D49 and Day 0
Responder rate according to OARSI-OMERACT criteria
Time frame: At Day 49
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 30 Dec 2016.
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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.
Philippe THOUMIE, MD principal investigator
Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebel Reliever in people with Osteoarthritis, Knee, run by Thuasne 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?
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 30 Dec 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evolution of the last 24 hours knee pain (VAS) (time frame: Between Day 49 and Day 0). 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 30 Dec 2016.