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 (PAAF)

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.

Study Overview

• Status: Completed
• Conditions: Femoral Fracture

• Study Type: Observational
• Enrollment (Actual): 255

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Chu Angers
  • Cholet, France
    • Ch Cholet
  • La Roche sur Yon, France
    • Centre Hospitalier Départemental VENDEE
  • La Rochelle, France
    • CH La Rochelle
  • Saint-Malo, France
    • CH Saint Malo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-fractural and 6 months after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Romain DECOURS, CHD Vendee

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: CHD117-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No