Recruitment

Recruitment Status
Completed
Estimated Enrollment
118

Inclusion Criteria

Male or female over 18 years
BMI < or egal to 35kg/m2
diagnosis of medial femoro-tibial knee osteoarthrosis
...
Male or female over 18 years
BMI < or egal to 35kg/m2
diagnosis of medial femoro-tibial knee osteoarthrosis
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)
patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection

Exclusion Criteria

hepatic or renal insufficiency
on going knee viscosupplementation at inclusion
any other serious disease which may interfere with the results
...
hepatic or renal insufficiency
on going knee viscosupplementation at inclusion
any other serious disease which may interfere with the results
skin lesions or dermal pathologies
other knee diseases
venous or arterial disorders
opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
septic arthritis
sensitivity disorders in the lower limbs (diabetes mellitus..)
slow acting OA drugs (if started in the last 2 months prior to inclusion)
psychiatrics disorders
paracetamol intolerance
pregnant women of with no contraception
symptomatic coxarthrosis
hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
chronical rheumatismal diseases
metabolic arthropathies
controlateral gonathrosis with corticoids injections
femoro-patellar predominant arthrosis

Summary

Conditions
  • Osteoarthritis (Knee)
  • Osteoarthritis, Knee
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 pa...

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.

Inclusion Criteria

Male or female over 18 years
BMI < or egal to 35kg/m2
diagnosis of medial femoro-tibial knee osteoarthrosis
...
Male or female over 18 years
BMI < or egal to 35kg/m2
diagnosis of medial femoro-tibial knee osteoarthrosis
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)
patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection

Exclusion Criteria

hepatic or renal insufficiency
on going knee viscosupplementation at inclusion
any other serious disease which may interfere with the results
...
hepatic or renal insufficiency
on going knee viscosupplementation at inclusion
any other serious disease which may interfere with the results
skin lesions or dermal pathologies
other knee diseases
venous or arterial disorders
opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
septic arthritis
sensitivity disorders in the lower limbs (diabetes mellitus..)
slow acting OA drugs (if started in the last 2 months prior to inclusion)
psychiatrics disorders
paracetamol intolerance
pregnant women of with no contraception
symptomatic coxarthrosis
hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
chronical rheumatismal diseases
metabolic arthropathies
controlateral gonathrosis with corticoids injections
femoro-patellar predominant arthrosis

Tracking Information

NCT #
NCT02021136
Collaborators
Not Provided
Investigators
  • Principal Investigator: Philippe THOUMIE, MD Coordinator
  • Philippe THOUMIE, MD Coordinator
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