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

T

THUASNE

Status and phase

Completed
Phase 3

Conditions

Osteoarthritis, Knee

Treatments

Device: Rebel Reliever
Other: Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT02021136
2013-A00613-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

67 participants in 2 patient groups

Rebel reliever
Experimental group
Description:
Rebel Reliever(R) knee brace + usual antalgic treatment + physical exercises recommendations.
Treatment:
Device: Rebel Reliever
Control
Active Comparator group
Description:
usual antalgic treatment + physical exercises recommendations.
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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