- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01400529
Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey (3000ARTHROSE)
Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey. Programme de Recherche du Groupe Qualité de Vie, de la Section Epidémiologie et de la Section Arthrose de la Société Française de Rhumatologie
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Osteoarthritis (OA) is a degenerative disease progressively affecting joint cartilage and subchondral bone, leading to pain, limited range of motion and functional impairment. Knee and hip are the more frequently affected joints. There is no treatment able to cure OA or at least to slow down cartilage damage. Thus, when symptomatic treatments become ineffective, joint prosthetic replacement is the unique solution.
There is a substantial lack of information about osteoarthritis (OA) epidemiology in France, as well as in other European countries, which becomes more and more critical with population aging. The need for additional knowledge was outlined in the law about public health priorities in France, published on August 9th, 2004. In this document, a specific call is made for additional investigation on functional limitations, disability and quality of life modification of people affected by OA.
Up to now, available information is mainly limited to short- or medium-term studies, conducted in clinic-based samples. Thus, based on demography and public health conclusions, implementing population-based epidemiologic studies is required in order to improve scientific knowledge with regards to :
- prevalence of symptomatic OA,
- its natural history over years and potential prognostic factors influencing the disease,
- its impact in terms of quality of life changes, disability, lack of autonomy and health resource use.
Our expert group, which has a substantial experience in osteoarthritis, epidemiology and health service research, has developed a 2-part research program aiming to help answering to OA-related public health questions:
- Part 1: a nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence, based on a validated method previously used to assess inflammatory rheumatism (rheumatoid arthritis and spondylarthropathy) prevalence in France.
- Part 2: the constitution of a population-based cohort of OA patients, aiming to collect clinical, biologic and radiological data about OA natural history, predictors of structural progression, consequences on quality of life, function and health resource use.
The present study is the part 1 of the program
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Amiens, Francia, 80054
- Service de Rhumatologie. CHU d'Amiens
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Brest, Francia, 29609
- Service de Rhumatologie. CHU de la Cavale Blanche
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Nancy, Francia, 54035
- Centre d'Epidémiologie Clinique. Service de rhumatologie. CHU Nancy
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Nice, Francia, 06202
- Service de Rhumatologie. CHU L'Archet 1
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Paris, Francia, 75651
- Service de Rhumatologie. Hôpital de la Pitié-Salpêtrière
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Toulouse, Francia, 31059
- Service de Rhumatologie. Hôpital Rangueil
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- age 40-75
- adults in households representative of the French population for age, sex, area of living and number of household members.
Exclusion Criteria:
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Francis Guillemin, MD, PhD, Societe Francaise de Rhumatologie
Pubblicazioni e link utili
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 906297
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .