ITMO public health
Last update : 06/24/2014 | Version : 1 | ID : 60148
| General | |
| Identification | |
| Detailed name | Adaptation of locomotor activity in patients suffering from hip osteoarthritis |
| Sign or acronym | LOCOX |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 28/04/2008 |
| General Aspects | |
| Medical area |
Rheumatology |
| Others (details) | Hip osteoarthritis |
| Keywords | total hip replacement, Health episodes, indication |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bonithon-Kopp |
| Surname | Claire |
| Address | 21000 DIJON |
| bonithon@u-bourgogne.fr | |
| Unit | CHU DIJON / INSERM CIE 1 UNIVERSITÉ DE BOURGOGNE |
| Organization | CHU |
| Name of the director | Maillefert |
| Address | 21000 DIJON |
| Phone | + 33 (0)3 80 29 37 45 |
| Unit | CHU DIJON |
| Organization | CHU |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | PHRC NATIONAL 2004 ET CHU DE DIJON |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Dijon |
| Organisation status |
Public |
| 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 Inclusion cut-off date: 01/10/2009 |
| Database objective | |
| Main objective | General objective: to assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip osteoarthritis for subsequent indications for total hip replacement. Analysis of the adaptation of locomotor activity as a prognostic criterion for future disease progression. |
| Inclusion criteria | Men and women aged between 45 and 75 years - suffering from primary hip osteoarthritis defined according to ACR criteria; - presented pain in the hip for at least one month in the preceding 3 months; - radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification; - able to understand simple instructions, packaging instructions and give their informed consent. Exclusion criteria - indication of total hip replacement at the time of inclusion; - pregnant or breast-feeding women; - Alzheimer's disease; - chronic respiratory insufficiency with clinical manifestations; - Parkinson's disease; - motor neuron disease; - major musculo-skeletal disorder (other than hip osteoarthritis); - severe non-stabilised diabetes; - non-stabilised hypertension; - hip osteoarthritis inflammation flare; - rapidly destructive hip osteoarthritis; - radiography to evaluate structural evolution of the disease done more than six months previously; - Presence of osteoarthritis in another joint, or another osteoarticular or periarticular disease of the lower limbs with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip osteoarthritis; - Spinal disease causing gait disturbance (radiculalgia, lumbar canal stenosis,… with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip osteoarthritis.). |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Bourgogne Franche-Comté |
| Detail of the geography area | Dijon |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 02/2008 |
| Date of last collection (YYYY or MM/YYYY) | 10/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 35 patients |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Measurement of locomotor activity on specific platform |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Self-administered questionnaire: from paper questionnaire (manual input) and double data entry Interview: from paper questionnaire (manual input) with double data entry Clinical Examinations: handwritten (manual input) with double data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 5 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams To be decided if data may 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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