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

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ClinicalTrials.gov Identifier: NCT00481338
Recruitment Status : Active, not recruiting
First Posted : June 1, 2007
Last Update Posted : August 3, 2015
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment
Hip Osteoarthritis Knee Osteoarthritis Procedure: X-rays Biological: biological samples Other: medical information about osteoarthritis

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 878 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : April 2007
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Quality of life, patient reported outcome measures [ Time Frame: every year, up to 10 years ]

Secondary Outcome Measures :
  1. health care consumption [ Time Frame: every year, up to 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481338

Patrice Fardellone
Amiens, France
CHU de la Cavale Blanche
Brest, France, 29609
CHU Nancy, hopital brabois
Nancy, France, 54035
CHU l'Archet
Nice, France, 06202
Hôpital de la Pitié-Salpêtrière
Paris, France, 75651
CHU Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Central Hospital, Nancy, France
Principal Investigator: Francis Guillemin, MD, PhD CHU Nancy (promoteur)

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT00481338     History of Changes
Other Study ID Numbers: DGS2006-0146
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

Keywords provided by Central Hospital, Nancy, France:
Quality of life
Health resource use

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases