Overview

This trial is active, not recruiting.

Conditions hip osteoarthritis, knee osteoarthritis
Treatments x-rays, biological samples, medical information about osteoarthritis
Sponsor Central Hospital, Nancy, France
Start date April 2007
End date March 2019
Trial size 878 participants
Trial identifier NCT00481338, DGS2006-0146

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
X-rays, biological samples and medical information about osteoarthritis
x-rays
X-rays (hip and knee) every 2 years
biological samples
biological sample (blood and urine) every 2 years
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

Primary Outcomes

Measure
Quality of life, patient reported outcome measures
time frame: every year, up to 10 years

Secondary Outcomes

Measure
health care consumption
time frame: every year, up to 10 years

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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

Additional Information

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
Principal investigator Francis Guillemin, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Central Hospital, Nancy, France.