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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)

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ClinicalTrials.gov Identifier: NCT03810092
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Study Description
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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.

Condition or disease
Femoral Fracture

Study Design
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Study Type : Observational
Estimated Enrollment : 255 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin rate [ Time Frame: 5 days after surgery ]
  2. Questionnaire Activities of Daily Living [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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 (which was treated in the Emergency Department of the Centre Hospitalier Départemental de Vendée).
Criteria

Inclusion Criteria:

  • Age ≥ 75 years
  • Patient operated on a fracture of the upper extremity of the femur (treatment in the emergency room of the CHD Vendée)
  • 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 deprived of liberty
  • Patient not affiliated to a social security system
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810092


Contacts
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Contact: Chloé MOREAU 0251446572 chloemoreau@chd-vendee.fr

Locations
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France
Centre Hospitalier Départemental Vendée Recruiting
La Roche sur Yon, France
Principal Investigator: Romain DECOURS         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Romain DECOURS CHD Vendée
More Information
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03810092     History of Changes
Other Study ID Numbers: CHD117-17
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries