Morality Clinical Trial
— FESF-AmiensOfficial title:
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
| NCT number | NCT03117868 |
| Other study ID # | RNI2016-04 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2, 2016 |
| Est. completion date | November 28, 2017 |
| Verified date | July 2020 |
| Source | Centre Hospitalier Universitaire, Amiens |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Fractures of the upper femur (EFSF) represent a major public health problem in the elderly.
Approximately 1.6 million patients are victims each year of an EFSF and this number is
increasing as a result of the aging of the population.
In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of
the fracture. In surviving patients, the impact on loss of autonomy and degradation of
quality of life is considerable.
The reduction of the incidence of post-operative complications includes the identification of
risk factors.
No prospective study in Amiens has investigated the mortality and the study of the variables
involved in the prognosis and long-term mortality of these patients.
| Status | Completed |
| Enrollment | 310 |
| Est. completion date | November 28, 2017 |
| Est. primary completion date | November 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens - Patients transferred to the CHU after being cared for in another structure will be included. - If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized Exclusion Criteria: - Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example) - Fractures of the upper end of the femur associated with polytrauma will not be included. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Amiens Picardie | Amiens | Picardie |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire, Amiens |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality at 6 months of EFSF patients | 6 months |
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