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

NCT ID: NCT00481338

Last Updated: 2015-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Osteoarthritis Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Study specific procedure

X-rays, biological samples and medical information about osteoarthritis

Group Type EXPERIMENTAL

X-rays

Intervention Type PROCEDURE

X-rays (hip and knee) every 2 years

biological samples

Intervention Type BIOLOGICAL

biological sample (blood and urine) every 2 years

medical information about osteoarthritis

Intervention Type OTHER

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

Interventions

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X-rays

X-rays (hip and knee) every 2 years

Intervention Type PROCEDURE

biological samples

biological sample (blood and urine) every 2 years

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis Guillemin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Nancy (promoteur)

Locations

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Patrice Fardellone

Amiens, , France

Site Status

CHU de la Cavale Blanche

Brest, , France

Site Status

CHU Nancy, hopital brabois

Nancy, , France

Site Status

CHU l'Archet

Nice, , France

Site Status

Hôpital de la Pitié-Salpêtrière

Paris, , France

Site Status

CHU Rangueil

Toulouse, , France

Site Status

Countries

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France

References

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Garnero P, Guillemin F, Ngueyon Sime W, Gineyts E, Chapurlat R, Roux C. Cartilage turnover, but not novel synovial collagen marker, is associated with joint damage progression in osteoarthritis patients. Rheumatology (Oxford). 2025 Sep 26:keaf510. doi: 10.1093/rheumatology/keaf510. Online ahead of print.

Reference Type DERIVED
PMID: 41002273 (View on PubMed)

Other Identifiers

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DGS2006-0146

Identifier Type: -

Identifier Source: org_study_id

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