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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee osteoarthritis | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum and urine samples collections | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS) | 12 month |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Knee prosthesis during the study | 12 month | |
| MRI cartilage volume (optional) | 12 month | |
| MRI T2 relaxation time (optional) |
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:
or at least 1 out of 3 clinical severity criteria:
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:
For previous treatments:
• Treatment with strontium ranelate, bisphosphonates, SERM and PTH
For known associated diseases:
For patients:
For MRI contraindications:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Liege-CHU | Liège | 4000 | Belgium | |||
| University Hospital of Nancy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34128409 | Derived | Hick AC, Malaise M, Loeuille D, Conrozier T, Maugars Y, Pelousse F, Tits C, Henrotin Y. Cartilage Biomarkers Coll2-1 and Coll2-1NO2 Are Associated with Knee OA MRI Features and Are Helpful in Identifying Patients at Risk of Disease Worsening. Cartilage. 2021 Dec;13(1_suppl):1637S-1647S. doi: 10.1177/19476035211021892. Epub 2021 Jun 15. | |
| 31631693 |
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| Imaging (x-rays and MRI) | Other | MRI will be done at baseline and 12 month and x-rays will be done at baseline |
|
| 12 month |
| MRI MOAKS scoring (optional) | 12 month |
| Nancy |
| France |
| Hick AC, Fonck M, Costes B, Cobraiville E, Pirson S, Garcia L, Labasse A, Vander Poelen S, Henrotin Y. Serum Levels of Coll2-1, a Specific Biomarker of Cartilage Degradation, Are Not Affected by Sampling Conditions, Circadian Rhythm, and Seasonality. Cartilage. 2021 Dec;13(1_suppl):540S-549S. doi: 10.1177/1947603519878489. Epub 2019 Oct 20. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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