Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS® (MOKHA)

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Hyaluronic acid, MRI, Biomarkers, Cartilage, pain Read More

Inclusion Criteria:

• Male or female between the age of 40 and 80 with BMI ≤ 40

• Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee OA associated or not with femoropatellar knee OA

  • Responding to clinical and radiological criteria of the American College of Rheumatology (ACR) (Appendix 1)
  • Symptomatic for more than 6 months in the most painful knee
  • Radiological Kellgren & Lawrence (K&L) II or III in radiographs from less than 12 months (Appendix 2)
• Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40 (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the half-life of the drug (Appendix 4). The most painful knee is considered.
• Able to follow the instructions of the study
• Having signed an ICF

Exclusion Criteria:

Related to the OA pathology

• Bilateral (except asymptomatic and grade I) OA of the knee
• Radiological K&L grade I or IV (Appendix 2)
• Chondromatosis or villonodular synovitis of the knee
• Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
• Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix 5)
• Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis….
• Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis
• Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)
• Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic)

Related to treatments

• Corticosteroids injection in the target knee in the last month before first injection
• Hyaluronan injection in the target knee in the last 6 months before first injection
• Arthroscopy and surgery in the target knee in the last 6 months before first injection
• Oral corticotherapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first injection
• OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection
• Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy unsaponifiables in the last 3 months before first injection
• Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug, Appendix 4).
• Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection
• An anticipated need for any forbidden OA treatments during the trial
• Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site.
• Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection
• Anticoagulant (coumarinic compound) and heparin

Related to associated diseases

• Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….)
• Allergy or contra-indication to hyaluronan
• Severe alteration of mobility enabling functional evaluation
• High risk of hemorrhage and risk of infection at the site of injection
• Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee

Related to patients

• Participation to a therapeutic clinical trial in the last 3 months before first injection
• Under guardianship or judicial protection
• Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy

Related to MRI counter-indication

• Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
• Patient with a ferromagnetic splinter in the body, or having wire sutures
• Serious mobility problem (Parkinson, tremors),
• Claustrophobia