Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

Femoral Fracture Clinical Trial

— PAAF  

Official title:

Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810092
• Other study ID #: CHD117-17
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Fractures, Bone

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CH Cholet	Cholet
France	Centre Hospitalier Départemental Vendée	La Roche sur Yon
France	CH La Rochelle	La Rochelle
France	CH Saint Malo	Saint-Malo

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin rate		5 days after surgery
Primary	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.	Pre-fractural and 6 months after surgery