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

Completed

• Conditions: Femoral Fracture

• Registration Number: NCT03810092
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-05-20
• Status Verified: 2023-04
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin rate	5 days after surgery
Questionnaire Activities of Daily Living	Pre-fractural and 6 months after surgery	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.

Trial Locations

Locations (5)

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, France