Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis (ROTOR)
December 29, 2016 updated by: Thuasne
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bp 80325
-
Joue-les-tours, Bp 80325, France, 37303
- Euraxi Pharma
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rebel reliever
Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.
|
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
|
|
Active Comparator: Control
usual antalgic treatment + physical exercises recommendations.
|
Usual antalgic treatment + physical exercises recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evolution of the last 24 hours knee pain (VAS)
Time Frame: Between Day 49 and Day 0
|
Between Day 49 and Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evolution of knee pain on movement (VAS)
Time Frame: Between Day 49 and Day 0
|
Evaluation with Visual Analysis Scale
|
Between Day 49 and Day 0
|
|
Evolution of Lequesne Algofunctional index score
Time Frame: Between D49 and Day 0
|
Between D49 and Day 0
|
|
|
Responder rate according to OARSI-OMERACT criteria
Time Frame: At Day 49
|
At Day 49
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of patients with at least one adverse event or serious adverse event in each groups.
Time Frame: during the 6 weeks of brace wearing
|
during the 6 weeks of brace wearing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philippe THOUMIE, MD, Coordinator
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
October 14, 2013
First Submitted That Met QC Criteria
December 19, 2013
First Posted (Estimate)
December 27, 2013
Study Record Updates
Last Update Posted (Estimate)
December 30, 2016
Last Update Submitted That Met QC Criteria
December 29, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A00613-42 (Other Identifier: ANSM number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.