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

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: Osteoarthritis, Knee
• Intervention / Treatment: Device: Rebel Reliever; Other: Control

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

Study Locations

• France
  • Bp 80325
    • Joue-les-tours, Bp 80325, France, 37303
      • Euraxi Pharma

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of the last 24 hours knee pain (VAS)	Between Day 49 and Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of knee pain on movement (VAS)	Evaluation with Visual Analysis Scale	Between Day 49 and Day 0
Evolution of Lequesne Algofunctional index score		Between D49 and Day 0
Responder rate according to OARSI-OMERACT criteria		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.	during the 6 weeks of brace wearing

Collaborators and Investigators

• Sponsor: Thuasne
• Investigators: Principal Investigator: Philippe THOUMIE, MD, Coordinator

Study record dates

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: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2013-A00613-42 (Other Identifier: ANSM number)