Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey (3000ARTHROSE)

This study has been completed.
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01400529
First received: July 5, 2007
Last updated: July 21, 2011
Last verified: July 2007
  Purpose

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.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Enrollment: 3000
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   40 Months to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

population based

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400529

Locations
France
Service de Rhumatologie. CHU d'Amiens
Amiens, France, 80054
Service de Rhumatologie. CHU de la Cavale Blanche
Brest, France, 29609
Centre d'Epidémiologie Clinique. Service de rhumatologie. CHU Nancy
Nancy, France, 54035
Service de Rhumatologie. CHU L'Archet 1
Nice, France, 06202
Service de Rhumatologie. Hôpital de la Pitié-Salpêtrière
Paris, France, 75651
Service de Rhumatologie. Hôpital Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Francis Guillemin, MD, PhD Société Française de Rhumatologie
  More Information

No publications provided

Responsible Party: Philippe Boulangé, direction de la recherche et de l'innovation, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01400529     History of Changes
Other Study ID Numbers: 906297
Study First Received: July 5, 2007
Last Updated: July 21, 2011
Health Authority: France: French Data Protection Authority

Keywords provided by Central Hospital, Nancy, France:
Osteoarthritis
knee
hip
population based

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014