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Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis (ROTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021136
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Thuasne

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Rebel Reliever Other: Control Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : October 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Rebel reliever
Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.
Device: Rebel Reliever
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations

Active Comparator: Control
usual antalgic treatment + physical exercises recommendations.
Other: Control
Usual antalgic treatment + physical exercises recommendations




Primary Outcome Measures :
  1. Evolution of the last 24 hours knee pain (VAS) [ Time Frame: Between Day 49 and Day 0 ]

Secondary Outcome Measures :
  1. Evolution of knee pain on movement (VAS) [ Time Frame: Between Day 49 and Day 0 ]
    Evaluation with Visual Analysis Scale

  2. Evolution of Lequesne Algofunctional index score [ Time Frame: Between D49 and Day 0 ]
  3. Responder rate according to OARSI-OMERACT criteria [ Time Frame: At Day 49 ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021136


Locations
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France
Euraxi Pharma
Joue-les-tours, Bp 80325, France, 37303
Sponsors and Collaborators
Thuasne
Investigators
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Principal Investigator: Philippe THOUMIE, MD Coordinator
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Responsible Party: Thuasne
ClinicalTrials.gov Identifier: NCT02021136    
Other Study ID Numbers: 2013-A00613-42
2013-A00613-42 ( Other Identifier: ANSM number )
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases