NCT05150249

Brief Summary

The study aims to collect the clinical activity and management data of the Orthogeriatrics and Orthopedics Units participating in the study on a continuous and long-term basis. By collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

6.5 years

First QC Date

November 25, 2021

Last Update Submit

July 24, 2025

Conditions

Keywords

GIOG ( Italian Society of Anesthesiology);geriatricorthogeriatricco-management

Outcome Measures

Primary Outcomes (1)

  • Compare the management and clinical methods

    Compare the management and clinical methods of the various centers and evaluate the relationship between indicators of treatment adherence to international guidelines and the short and long-term outcomes of patients.

    Entire study duration, approximately 5 years

Secondary Outcomes (5)

  • Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group

    Entire study duration, approximately 5 years

  • Improvement of clinical practice

    Entire study duration, approximately 5 years

  • Improvement of collaboration of specialists from various disciplines

    Entire study duration, approximately 5 years

  • Increase the sensitivity of doctors and operators on the problems of the elderly population with hip fracture between participating centers

    Entire study duration, approximately 5 years

  • Enhance the model of orthogeriatrics and geriatric-orthopedic management

    Entire study duration, approximately 5 years

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients with a fracture of the femur in which there is a co-management of the clinical problems of the elderly patient between orthopedists and geriatricians

You may qualify if:

  • Fracture of the femur, regardless of the cause
  • Age ≥ 65 years
  • Willingness to participate in the study by the patient or a relative / caregiver, if the patient is unable to understand and is not "competent" at the time of the evaluation.
  • Able to speak the Italian language

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ospedale S. Agostino Estense

Baggiovara, Italy

RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Italy

RECRUITING

Ospedale Centrale di Bolzano

Bolzano, Italy

RECRUITING

ASST Vimercate - Ospedale di Carate Brianza

Carate Brianza, Italy

RECRUITING

Arcispedale Sant'Anna

Ferrara, Italy

RECRUITING

A.O.U. di Careggi

Florence, Italy

RECRUITING

Azienda Usl Toscana centro

Florence, Italy

RECRUITING

Ospedale Galliera Genova

Genova, Italy

RECRUITING

Ospedale Policlinico S. Martino

Genova, Italy

RECRUITING

Policlinico Universitario Campus Bio-Medico

Roma, Italy

RECRUITING

ASST della Valtellina e dell'Alto Lario

Sondrio, Italy

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Giuseppe Belelli, Proff.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 9, 2021

Study Start

July 15, 2019

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations