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

July 31, 2015 updated by: Central Hospital, Nancy, France

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

878

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Patrice Fardellone
      • Brest, France, 29609
        • CHU de la Cavale Blanche
      • Nancy, France, 54035
        • CHU Nancy, hopital brabois
      • Nice, France, 06202
        • CHU L'Archet
      • Paris, France, 75651
        • Hôpital de la Pitié-Salpêtrière
      • Toulouse, France, 31059
        • CHU Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study specific procedure
X-rays, biological samples and medical information about osteoarthritis
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Francis Guillemin, MD, PhD, CHU Nancy (promoteur)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (Estimate)

June 1, 2007

Study Record Updates

Last Update Posted (Estimate)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 31, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS2006-0146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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