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Prevalence,Natural History,Prognosis Factor,QualityofLife,Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France (KHOALA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00481338
First received: May 31, 2007
Last updated: July 21, 2011
Last verified: April 2009
History of Changes
  Purpose

The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients.

General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.


Condition Intervention
Hip Osteoarthritis
Knee Osteoarthritis
 Procedure: X-rays
Biological: biological samples
Other: medical information about osteoarthritis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Knee and Hip OsteoArthritis Long Term Assessment. Prevalence, Natural History, Prognosis Factor, Quality of Life, Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Quality of life, patient reported outcome measures [ Time Frame: every year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health care consumption [ Time Frame: every year ] [ Designated as safety issue: No ]

Enrollment: 878
Study Start Date: April 2007
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: X-rays
    X-rays (hip and knee) every 2 years
    Biological: biological samples
    biological sample (blood and urine) every 2 years
    Other: medical information about osteoarthritis
    several questionnaires about pain and function (WOMAC), physical activity (MAQ), quality of life (generic SF-36 and OA specific OAKHQOL/AMIQUAL), comorbidities (FCI), mental status (MMS), heath status (GHQ 28) and health resource consumption
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female aged between 40 and 75 years
  • symptomatic hip or knee, uni or bilateral OA with clinical diagnosis confirmed by a medical physician and satisfying ACR classification criteria
  • Representative of prevalent cases in France at the cohort set-up time

Exclusion Criteria:

  • presence of hip or knee joint replacement surgery
  • comorbidities severe enough to affect quality of life significantly or likely to induce a high health care consumption independently of OA
  • an history of osteotomy
  • Patello-femoral osteoarthritis without tibio-femoral osteoarthritis
  • Other joint diseases of the target joints
  • adult under legal protection or not able to consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481338

Locations
France
Patrice Fardellone
Amiens, France
CHU de la Cavale Blanche
Brest, France, 29609
CHU Nancy, hopital brabois
Nancy, France, 54035
CHU l'Archet
Nice, France, 06202
Hôpital de la Pitié-Salpêtrière
Paris, France, 75651
CHU Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Francis Guillemin, MD, PhD CHU Nancy (promoteur)
  More Information

No publications provided

Responsible Party: Philippe Boulangé, Direction de la Recherche et de l'Innovation
ClinicalTrials.gov Identifier: NCT00481338     History of Changes
Other Study ID Numbers: DGS2006-0146
Study First Received: May 31, 2007
Last Updated: July 21, 2011
Health Authority: France: Ministry of Health

Keywords provided by Central Hospital, Nancy, France:
Cohort
Quality of life
Health resource use
Disability
Prognosis

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

ClinicalTrials.gov processed this record on May 21, 2013