Mortality of Patients Undergoing Fracture of the Upper Ex... | NCT03117868

Studies
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens

NCT03117868

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Completed

Last Update Posted

Jul 20, 2020Actual

Enrollment

310Actual

Phase

Not provided

Conditions

Femur Fracture
Morality

Interventions

Study of mortality at 6 months

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2016Actual

Primary Completion Date

Nov 28, 2017Actual

Completion Date

Nov 28, 2017Actual

First Submitted Date

Apr 13, 2017

First Submission Date that Met QC Criteria

Apr 13, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2020

Last Update Posted Date

Jul 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study of mortality at 6 months	Other	The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF

Measure	Description	Time Frame
Mortality at 6 months of EFSF patients		6 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens Picardie		Amiens	Picardie	80054	France

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided