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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2019

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Study specific procedure
    • X-rays, biological samples and medical information about osteoarthritis

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life, patient reported outcome measures
    • Time Frame: every year, up to 10 years

Secondary Measures

  • health care consumption
    • Time Frame: every year, up to 10 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Francis Guillemin, MD, PhD, Principal Investigator, CHU Nancy (promoteur)

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