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Knee osteoarthritis (OA) is an heterogeneous disease, both symptomatically and structurally, with very different evolving profiles. Although several serum, urinary or synovial biomarkers have been developed in knee OA, their interest as potential predictive factors of clinical and structural progression remains poorly known. Similarly, to date, no biological predictive markers of response to OA treatments have been validated, particularly for intra-articular treatments [corticosteroids (CTC), hyaluronic acid (HA), platelet-rich plasma (PRP)]. Finally, although cohorts of OA patients have already been established in the past, none of them has made it possible to establish a biobank of serum and synovial fluid obtained from the same patient at inclusion but also during the follow-up of the OA disease, up to the joint replacement.
The investigators hypothesize that some biomarkers in serum, PRP and synovial fluid in knee OA:
To validate theses hypothesis, investigators will conduct a longitudinal cohort study with long term follow-up until joint replacement in patients with knee OA. In parallel to this longitudinal study, a cross-sectional ancillary study will be conducted to compare the levels of different serum and synovial biomarkers between subjects with knee OA and subjects with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis)
A/ Main objectives:
- Longitudinal study To study the correlations between changes in clinical symptoms (pain, function, quality of life, effusion, flare-up) / radiographic progression during the follow-up on the one hand, and the levels of biomarkers in serum, PRP and synovial fluid at inclusion / their variations at different times of the study on the other hand.
B/ Secondary objectives
Longitudinal study
Cross-sectional study
Method:
300 patients with knee pain related to knee OA (n=200) or chronic inflammatory rheumatism (spondylarthritis and rheumatoid arthritis) (n=100) requiring arthrocentesis and/or intra-articular injection will be enrolled in the Rheumatology department from Henri Mondor Hospital. A longitudinal follow-up will be proposed to patients with knee OA in addition to the participation in the cross-sectional study. The follow-up will include at least one visit each year or more in case of painful flare-up or new intra-articular injection. The follow-up will last a maximum of 10 years or less in case of joint replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with knee osteoarthritis |
| ||
| patients with knee arthritis related to chronic inflammatory rheumatism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA brief descriptive name used to refer to the intervention(s) studied | Other | Details that can be made public about the intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of pain on a 0-100mm VAS from baseline clinical phenotype of OA patients through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Evaluation of the radiological phenotype | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Changes of WOMAC score A, B, C and WOMAC total from baseline clinical phenotype of OA patients through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Changes of Lequesne score from baseline clinical phenotype of OA patients through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Changes of quality of life index defined by EQ5D-5L from baseline clinical phenotype of OA patients through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Changes of KOFUS score from baseline clinical phenotype of OA patients through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pain on a VAS 0-100mm for patients with knee OA | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Assessment of the effusion for patients with knee OA |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients consulting the department for puncture and/or infiltration for gonalgia in the context of knee osteoarthritis or knee arthritis related to chronic inflammatory rheumatism.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florent EYMARD, MD, PhD | Contact | +33149812701 | florent.eymard@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Florent EYMARD, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor | Recruiting | Créteil | 94000 | France |
No DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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| Changes of DN4 Neuropathic Pain Score from baseline clinical phenotype of OA patients through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Obtention of an acceptable Symptom State assessed by the PASS (Patient Acceptable Symptom State) through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Occurrence of a clinical extension of OA disease (presence of a generalized disease in case of association of knee and hand OA) through study completion | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Worsening of radiographic lesions from baseline through study completion assessed by X-rays of the knees (frontal, lateral, Schuss and patellofemoral views) according to the Kellgren and Lawrence score | performed at baseline, every 2 years up to 10 years but also in case of congestive or painful flare-ups in target knee according to the Kellgren and Lawrence score | 10 years |
| Analysis of several blood markers [cartilage degradation markers (CTXII, col2-1, col2-1No), anabolic markers (PIIANP), cytokines (IL-6 and IL-8), ultra-sensitive CRP, proteoglycans (PG), glycosaminoglycans (GAG)] | performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion | 10 years |
| Analysis of several biological markers obtained from PRP [growth factors (FGF, TGF, PDGF, VEGF, IGF,...) and GAGs] | performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion | 10 years |
| Analysis of several biological markers obtained from synovial fluid [inflammatory cytokines IL-6 and IL-8, PG, GAG, metalloproteinases (MMP)]. | performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion | 10 years |
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
| 10 years |
| Assessment of the WOMAC score A, B, C and WOMAC total for patients with knee OA | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Assessment of the Lequesne score for patients with knee OA | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Assessment of the quality of life index defined by EQ5D-5L for patients with knee OA | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| Assessment of the KOFUS flare score for patients with knee OA | performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection | 10 years |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D012213 | Rheumatic Fever |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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