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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481338
First Posted: June 1, 2007
Last Update Posted: August 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Central Hospital, Nancy, France
  Purpose

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 Intervention
Hip Osteoarthritis Knee Osteoarthritis Procedure: X-rays Biological: biological samples Other: medical information about osteoarthritis

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

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

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

Enrollment: 878
Study Start Date: April 2007
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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


Locations
France
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
Investigators
Principal Investigator: Francis Guillemin, MD, PhD CHU Nancy (promoteur)
  More Information

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT00481338     History of Changes
Other Study ID Numbers: DGS2006-0146
First Submitted: May 31, 2007
First Posted: June 1, 2007
Last Update Posted: August 3, 2015
Last Verified: July 2015

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

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