FESF-Amiens: Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Completed
• CT.gov ID: NCT03117868
• Collaborator: (none)
• Enrollment: 310
• Location: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 17.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Femur Fracture; Morality	Other: Study of mortality at 6 months

Study Design

• Study Type: Observational
• Actual Enrollment: 310 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
• Actual Study Start Date: Jun 2, 2016
• Actual Primary Completion Date: Nov 28, 2017
• Actual Study Completion Date: Nov 28, 2017

Outcome Measures

Primary Outcome Measures

1. Mortality at 6 months of EFSF patients [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03117868
• Other Study ID Numbers: RNI2016-04
• First Posted: Apr 18, 2017
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone; Femoral Fractures

Study Results

No Results Posted as of Jul 20, 2020