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

NCT05105906 | Completed

• 1 other identifier: FPG ID 3993
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delirium; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time

  12 months assessment

Interventions

cognitive tests performed DIAGNOSTIC_TEST

cognitive tests performed

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Age \<65

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Giuliano Ferrone

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 3, 2021
• Study Start: May 1, 2021
• Primary Completion: May 25, 2024
• Study Completion: December 30, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)