Knee Osteoarthritis
Conditions
Brief summary
The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.
Interventions
OTHERSerum and urine samples collections
Serum and urine samples will be collected at baseline, 3 month, 6 month, 12 month to assess the predictive value of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 on OA progression (MRI, Clinical and radiological progression)
OTHERImaging (x-rays and MRI)
MRI will be done at baseline and 12 month and x-rays will be done at baseline
Sponsors
Artialis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS) | 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analogue Scales (VAS) for mean knee pain and global patient assessment of disease activity | 12 month |
Other
| Measure | Time frame |
|---|---|
| Knee prosthesis during the study | 12 month |
| MRI cartilage volume (optional) | 12 month |
| MRI T2 relaxation time (optional) | 12 month |
| MRI MOAKS scoring (optional) | 12 month |
Countries
Belgium, France
Outcome results
None listed