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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Rebel Reliever
Control
Sponsored by
Thuasne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Euraxi Pharma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rebel reliever

Control

Arm Description

Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.

usual antalgic treatment + physical exercises recommendations.

Outcomes

Primary Outcome Measures

Evolution of the last 24 hours knee pain (VAS)

Secondary Outcome Measures

Evolution of knee pain on movement (VAS)
Evaluation with Visual Analysis Scale
Evolution of Lequesne Algofunctional index score
Responder rate according to OARSI-OMERACT criteria

Full Information

First Posted
October 14, 2013
Last Updated
December 29, 2016
Sponsor
Thuasne
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1. Study Identification

Unique Protocol Identification Number
NCT02021136
Brief Title
Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis
Acronym
ROTOR
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rebel reliever
Arm Type
Experimental
Arm Description
Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
usual antalgic treatment + physical exercises recommendations.
Intervention Type
Device
Intervention Name(s)
Rebel Reliever
Intervention Description
Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual antalgic treatment + physical exercises recommendations
Primary Outcome Measure Information:
Title
Evolution of the last 24 hours knee pain (VAS)
Time Frame
Between Day 49 and Day 0
Secondary Outcome Measure Information:
Title
Evolution of knee pain on movement (VAS)
Description
Evaluation with Visual Analysis Scale
Time Frame
Between Day 49 and Day 0
Title
Evolution of Lequesne Algofunctional index score
Time Frame
Between D49 and Day 0
Title
Responder rate according to OARSI-OMERACT criteria
Time Frame
At Day 49
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe THOUMIE, MD
Organizational Affiliation
Coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Euraxi Pharma
City
Joue-les-tours
State/Province
Bp 80325
ZIP/Postal Code
37303
Country
France

12. IPD Sharing Statement

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

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