Last update : 09/12/2017 | Version : 2 | ID : 60059
General | |
Identification | |
Detailed name | Knee and Hip Osteoarthritis Long Term Assessment Cohort |
Sign or acronym | KHOALA |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 906297, CPP : 2006-A00587-44 (17.01.01), Afssaps : 2006-0146 |
General Aspects | |
Medical area |
Rheumatology |
Keywords | Prosthesis, quality of life, healthcare usage |
Scientific investigator(s) (Contact) | |
Name of the director | GUILLEMIN |
Surname | Francis |
Phone | +33 (0)3 83 85 21 63 |
francis.guillemin@chu-nancy.fr | |
Unit | CENTRE D'EPIDEMIOLOGIE CLINIQUE CIC-EC INSERM CIE6 NANCY. EA4003 CHU NANCY |
Organization | CHU |
Collaborations | |
Funding | |
Funding status |
Mixed |
Details | Inserm, CHU de NANCY, Société Française de Rhumatologie, InVS, CNAM Firmes industrielles |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | CHU Nancy |
Organisation status |
Public |
Presence of scientific or steering committees |
Yes |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Prospective Other bodies active in creating this cohort: SOCIETE DE RHUMATOLOGIE Closing date for inclusion: 01/08/2009 |
Database objective | |
Main objective | General objective: To describe the natural history of symptomatic hip and knee osteoarthritis and to to identify predictive factors of its consequences in terms of pain, functional incapacity, quality of life and healthcare (medical care, use of healthcare resources and illness cost). Patients for this cohort study are identified during a national prevalence study. Secondary objectives: - to investigate predictive factors for quality of life, changes in quality of life and hip or knee replacement such as: socio-demographic parameters, clinical factors, comorbidities, perceived health parameters at baseline (quality of life, functional capacity), x-rays and biological markers; - to identify factors that influence healthcare usage, social impact and treatment for symptomatic hip and knee osteoarthritis; - to collect and store biological samples (serum bank and DNA bank), x-rays, clinical and perceived health data in order to form a platform for other research projects, such as physiopathological projects on cellular and molecular mechanisms of osteoarthritis and genetic projects. This cohort will benefit from the advantages of the descriptive prevalence study and will allow the recruitment of a general population based representative sample. |
Inclusion criteria | - Men and women between 40 and 75 years of age - Symptomatic uni- or bilateral knee (tibio-femoral) and hip osteoarthritis with confirmed diagnosis that meets EULAR and ACR criteria, identified from prevalent cases in France during cohort formation |
Population type | |
Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) |
Population covered |
Sick population |
Gender |
Male Woman |
Geography area |
National |
French regions covered by the database |
Alsace Champagne-Ardenne Lorraine Bretagne Île-de-France Languedoc-Roussillon Midi-Pyrénées Nord - Pas-de-Calais Picardie Provence - Alpes - Côte d'Azur |
Detail of the geography area | Multicentric cohort throughout France (6 centres) |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 04/2007 |
Date of last collection (YYYY or MM/YYYY) | 04/2019 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 878 |
Data | |
Database activity |
Current data collection |
Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
Clinical data (detail) |
Direct physical measures Medical registration |
Declarative data (detail) |
Paper self-questionnaire Face to face interview |
Paraclinical data (detail) | Imaging |
Biological data (detail) | DNA, urine, serum samples |
Presence of a biobank |
Yes |
Contents of biobank |
Serum Fluids (saliva, urine, amniotic fluid, …) DNA |
Details of biobank content | Serum bank, DNA bank, urine |
Health parameters studied |
Health event/morbidity Health event/mortality |
Procedures | |
Data collection method | Self-administered questionnaire: input from a paper questionnaire; Interviews: input from a paper questionnaire Clinical examinations: handwritten. |
Participant monitoring |
Yes |
Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by convocation of the participant Monitoring by contact with the referring doctor |
Details on monitoring of participants | Follow-up duration: 10 years |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Link to the document | http://www.hal.inserm.fr/KHOALA |
Description | List of publications in HAL |
Link to the document | http://tinyurl.com/Pubmed-KHOALA |
Description | List of publications in Pubmed |
Access | |
Presence of document that lists variables and coding procedures |
Yes |
Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access conditions: networks working with UMR 7561 physiopathology, pharmacology and joint engineering pharmacology laboratory, Vandœuvre-lès-Nancy. Collaboration with external teams is planned. Access to the constructed database is permitted by a partnership charter, which has been developed and already exhibited, mainly to potential partners, during communication concerning the cohort at the French Rheumatology Congress in 2008. Data may not be used by industrial teams. |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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