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Clinical Trials/NCT00481338
NCT00481338UnknownNot Applicable

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

Central Hospital, Nancy, France6 sites in 1 country878 target enrollmentStarted: April 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
878
Locations
6
Primary Endpoint
Quality of life, patient reported outcome measures

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Study specific procedure

Experimental

X-rays, biological samples and medical information about osteoarthritis

Intervention: X-rays (Procedure)

Study specific procedure

Experimental

X-rays, biological samples and medical information about osteoarthritis

Intervention: biological samples (Biological)

Study specific procedure

Experimental

X-rays, biological samples and medical information about osteoarthritis

Intervention: medical information about osteoarthritis (Other)

Outcomes

Primary Outcomes

Quality of life, patient reported outcome measures

Time Frame: every year, up to 10 years

Secondary Outcomes

  • health care consumption(every year, up to 10 years)

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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