NCT00481338

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
878

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

11.9 years

First QC Date

May 31, 2007

Last Update Submit

July 31, 2015

Conditions

Hip OsteoarthritisKnee Osteoarthritis

Keywords

CohortQuality of lifeHealth resource useDisabilityPrognosis

Outcome Measures

Primary Outcomes (1)

  • Quality of life, patient reported outcome measures

    every year, up to 10 years

Secondary Outcomes (1)

  • health care consumption

    every year, up to 10 years

Study Arms (1)

Study specific procedure

EXPERIMENTAL

X-rays, biological samples and medical information about osteoarthritis

Procedure: X-raysBiological: biological samplesOther: medical information about osteoarthritis

Interventions

X-raysPROCEDURE

X-rays (hip and knee) every 2 years

Study specific procedure
biological samplesBIOLOGICAL

biological sample (blood and urine) every 2 years

Study specific procedure
medical information about osteoarthritisOTHER

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

Study specific procedure

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Patrice Fardellone

Amiens, France

Location

CHU de la Cavale Blanche

Brest, 29609, France

Location

CHU Nancy, hopital brabois

Nancy, 54035, France

Location

CHU l'Archet

Nice, 06202, France

Location

Hôpital de la Pitié-Salpêtrière

Paris, 75651, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 41002273DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Interventions

X-Rays

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Francis Guillemin, MD, PhD

    CHU Nancy (promoteur)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 1, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations

FR(6)