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

Knee Osteoarthritis Clinical Trial

— KHOALA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00481338
• Other study ID #: DGS2006-0146
• Status: Active, not recruiting
• Phase: N/A
• First received: May 31, 2007
• Last updated: July 31, 2015
• Start date: April 2007
• Est. completion date: March 2019

Study information

• Verified date: July 2015
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 878
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
France	Patrice Fardellone	Amiens
France	CHU de la Cavale Blanche	Brest
France	CHU Nancy, hopital brabois	Nancy
France	CHU l'Archet	Nice
France	Hôpital de la Pitié-Salpêtrière	Paris
France	CHU Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life, patient reported outcome measures		every year, up to 10 years	No
Secondary	health care consumption		every year, up to 10 years	No