Clinical trial NCT01400529: Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Osteoarthritis
knee
hip
population based
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: population based

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Service de Rhumatologie. CHU d'Amiens
city: Brest
country: France
facility: Service de Rhumatologie. CHU de la Cavale Blanche
city: Nancy
country: France
facility: Centre d'Epidémiologie Clinique. Service de rhumatologie. CHU Nancy
city: Nice
country: France
facility: Service de Rhumatologie. CHU L'Archet 1
city: Paris
country: France
facility: Service de Rhumatologie. Hôpital de la Pitié-Salpêtrière
city: Toulouse
country: France
facility: Service de Rhumatologie. Hôpital Rangueil
Study officials:
affiliation: Societe Francaise de Rhumatologie
name: Francis Guillemin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillemin F, Rat AC, Mazieres B, Pouchot J, Fautrel B, Euller-Ziegler L, Fardellone P, Morvan J, Roux CH, Verrouil E, Saraux A, Coste J; 3000 Osteoarthritis group. Prevalence of symptomatic hip and knee osteoarthritis: a two-phase population-based survey. Osteoarthritis Cartilage. 2011 Nov;19(11):1314-22. doi: 10.1016/j.joca.2011.08.004. Epub 2011 Aug 16.