FOTO - French observational survey about 3 months incidence of symptomatic venous thromboembolic events on patients with total hip or knee prosthesis
Head :
Samama Marc, U 765 Thrombose épidémiologie, physiopathologie et thérapeutiques innovantes
Barre Jeanne , Service du Pr Léon
Ravaud Philippe, Département d'Epidémiologie et de Biostatistique
Mismetti Patrick, Pavillon 5 - Service du Pr Queneau
Barre Jeanne , Service du Pr Léon
Ravaud Philippe, Département d'Epidémiologie et de Biostatistique
Mismetti Patrick, Pavillon 5 - Service du Pr Queneau
Last update : 07/23/2015 | Version : 2 | ID : 6855
| General | |
| Identification | |
| Detailed name | French observational survey about 3 months incidence of symptomatic venous thromboembolic events on patients with total hip or knee prosthesis |
| Sign or acronym | FOTO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Hematology |
| Keywords | Symptomatic thromboembolic events, total hip or knee prostheses |
| Scientific investigator(s) (Contact) | |
| Name of the director | Samama |
| Surname | Marc |
| Address | Hôpital Cochin |
| Phone | +33 (0)1 42 34 85 51 |
| marc.samama@cch.aphp.fr | |
| Unit | U 765 Thrombose épidémiologie, physiopathologie et thérapeutiques innovantes |
| Organization | Assistance Publique - Hôpitaux de Paris - Hôpital |
| Name of the director | Barre |
| Surname | Jeanne |
| Address | Avenue du Général Koening 51092 REIMS Cedex |
| Unit | Service du Pr Léon |
| Organization | Hôpital Robert |
| Name of the director | Ravaud |
| Surname | Philippe |
| Address | Hôtel Dieu de Paris |
| Phone | +33 (0)1 58 41 41 41 |
| philippe.ravaud@htd.aphp.fr | |
| Unit | Département d'Epidémiologie et de Biostatistique |
| Organization | Assistance Publique - Hôpitaux de |
| Name of the director | Mismetti |
| Surname | Patrick |
| Address | 25, boulevard Pasteur 42055 SAINT ETIENNE Cedex 2 |
| Phone | +33 (0)4 77 12 77 70 |
| mismetti@univ-st-etienne.fr | |
| Unit | Pavillon 5 - Service du Pr Queneau |
| Organization | Hôpital |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-Synthelabo |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Assistance Publique - Hôpitaux de Paris Hôpital Bichat |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Sanofi-Synthelabo |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| 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. | Representative sample of patients operated for a total hip or knee prostheses. Each investigator selects consecutively his patients scheduled for a total hip or knee prostheses |
| Database objective | |
| Main objective | Evaluating at 3 months the incidence of Symptomatic thromboembolic events |
| Inclusion criteria | Male or female, 18 years old or more, with total hip or knee prostheses |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France (130 orthopaedic centers) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2003 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1770 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization |
| Procedures | |
| Data collection method | At each patient corresponds a unique data collection form. Information is collected during the pre-operative examination, leaving the hospital and at 3 months. At 3 months, the patient will send back to his doctor the data collection form received before leaving the hospital, to get informed about his good health. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up for 3 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-FOTO |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Samama+OR+Barre+OR+Ravaud+OR+Mismetti%29+AND+foto |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
