- Written by ClinicalTrial.gov
- Category: Arthritis
Inclusion Criteria:
- Male or female, aged 45 to 80 years with a BMI ≤ 40
- With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a femoro-patellar knee osteoarthritis
- Responding to clinical and radiological criteria of the ACR
- Symptomatic for more than 6 months (for the most painful knee)
- K&L radiological grade of Felson II or III
With a cartilage lesion identified during MRI and either at least 1 out of 4 MRI severity criteria:
- bone oedema
- meniscal lesion in the central region of the medial compartment
- effusion without answer to corticosteroids
- zone without cartilage
or at least 1 out of 3 clinical severity criteria:
- genu varum>3°
- previous meniscal surgery
- known polyarthritis
- effusion on the target knee
- Sign an informed consent after being informed
- Able to follow the instructions of the study
- With an agreement from the physicians having established the diagnosis of osteoarthritis (if any) to give relevant information to the investigator
- With health insurance (for France).
Exclusion Criteria:
For osteoarthritis:
- Isolated patellofemoral arthritis
- Chondromatosis or villo-nodular synovioma of the knee
- Recent trauma-induced knee pain
- Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, …
- inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious arthritis
- Diseases that may interfere with the evaluation of osteoarthritis (radiculalgia of lower limbs, arteritis, …)
- Genu valgum (degree considered as pathological by the physician)
For previous treatments:
• Treatment with strontium ranelate, bisphosphonates, SERM and PTH
For known associated diseases:
- Serious associated diseases: severe liver or renal failure, uncontrolled cardiovascular disease, HIV, hepatitis B or C
- Knee tumor
For patients:
- Patient who participated to a therapeutic clinical trial 3 months before the T0 inclusion visit
- Patient who are the subject of a judicial protection measure or under guardianship
- Pregnant woman
For MRI contraindications:
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- Patient with a ferromagnetic splinter in the body, or having wire sutures
- Serious mobility problem (Parkinson, tremors)
Read more: http://www.clinicaltrials.gov/ct2/show/NCT02070224?cond=%22Arthritis%22&lup_s=01/29/2014&lup_d=30
- Details