NCT03810092

Brief Summary

Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

January 17, 2019

Results QC Date

September 2, 2025

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin Rate

    5 days after surgery

  • Questionnaire Activities of Daily Living

    For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points. A loss of autonomy will be defined by the decrease of one or more points in the ADL. Result showed here is the difference of ADL score intra patient

    Pre-fractural and 6 months after surgery

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

This study is intended for patients over 75 years of age who have had a fracture of the upper extremity of the femur operated on.

You may qualify if:

  • Age ≥ 75 years
  • Patient operated on a fracture of the upper extremity of the femur
  • Patient, family or close relative who does not object to participation in the study
  • Patient affiliated to a social security system
  • Patient who can be monitored as part of the protocol

You may not qualify if:

  • Refusal to participate in the study (patient, family or trusted relative)
  • Patient with support on the operated limb not authorized by the surgeon
  • Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
  • Patient with a pathologic fracture
  • Patient included in Category 1 interventional research (involving a drug or medical device)
  • Patient deprived of liberty
  • Patient not affiliated to a social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Angers

Angers, France

Location

CH Cholet

Cholet, France

Location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Location

CH La Rochelle

La Rochelle, France

Location

CH Saint Malo

St-Malo, France

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Results Point of Contact

Title
Romain DECOURS
Organization
CHD VENDEE

Study Officials

  • Romain DECOURS

    CHD Vendée

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

May 20, 2019

Primary Completion

April 12, 2023

Study Completion

April 12, 2023

Last Updated

September 19, 2025

Results First Posted

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations