Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Serum and urine samples collections
* Other: Imaging (x-rays and MRI)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Knee osteoarthritis<br> | Other: Serum and urine samples collections<br>* 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)<br>Other: Imaging (x-rays and MRI)<br>* MRI will be done at baseline and 12 month and x-rays will be done at baseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS) |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |