NCT03117868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

April 13, 2017

Last Update Submit

July 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality at 6 months of EFSF patients

    6 months

Interventions

The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients operated with an EFSF and meeting the inclusion criteria

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

June 2, 2016

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations