Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery

Post-operative Delirium (POD) Assessment in Patients Undergoing Hip Fracture Surgery

The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months.

The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life

Study Overview

• Status: Completed
• Conditions: Delirium; Cognitive Dysfunction
• Intervention / Treatment: Diagnostic test: cognitive tests performed

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All men and women over the age of 65 with clinical-radiological hip fracture presence will be enrolled

Description

Inclusion Criteria:

• Age > 65
• Clinical - radiological presence of hip fracture

Exclusion Criteria:

• Age <65

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appearance of POD within the first 3 months	Appearance of Post Operative Delirium within the first 3 months after hip surgery	3 months assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time	Development of Post Operative Cognitive Dysfunction, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time	12 months assessment

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Giuliano Ferrone, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 25, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Fractures, Bone; Femoral Fractures; Hip Injuries; Emergence Delirium; Delirium; Cognitive Dysfunction; Hip Fractures
• Other Study ID Numbers: FPG ID 3993

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