Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey

Osteoarthritis Clinical Trial

— 3000ARTHROSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400529
• Other study ID #: 906297
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: July 21, 2011
• Start date: March 2007
• Est. completion date: November 2009

Study information

• Verified date: July 2007
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Months to 75 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
France	Service de Rhumatologie. CHU d'Amiens	Amiens
France	Service de Rhumatologie. CHU de la Cavale Blanche	Brest
France	Centre d'Epidémiologie Clinique. Service de rhumatologie. CHU Nancy	Nancy
France	Service de Rhumatologie. CHU L'Archet 1	Nice
France	Service de Rhumatologie. Hôpital de la Pitié-Salpêtrière	Paris
France	Service de Rhumatologie. Hôpital Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France,