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Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group

Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05150249
Acronym
GIOG
Enrollment
7000
Registered
2021-12-09
Start date
2019-07-15
Completion date
2025-12-31
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comprehensive Geriatric Assessment, Hip Fractures, Older Patients

Keywords

GIOG ( Italian Society of Anesthesiology);, geriatric, orthogeriatric, co-management

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.

Detailed description

Multicenter prospective cohort observational study. The enrollment period will be 5 years. An additional 4 months will be required to allow the last enrolled patients to complete the 120-day follow-up. It is estimated to enroll a total of 7,000 patients. To facilitate the participation in the study of non-university or IRCCS assistance departments, two methods of data collection will be possible: * High intensity: continuous data collection for the whole period of the study on all the incident cases * Low intensity: data collection once a year on incident cases over a continuous period of 1 month, with a reduced number of variables. The choice of the level of intensity with regard to the data collection method will take place on a voluntary basis (each OU will actually choose the type of speed with which it intends to collaborate in the project, after communicating to the steering committee and to the biostatisticians of the study)

Interventions

None listed

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Compare the management and clinical methodsEntire study duration, approximately 5 yearsCompare 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.

Secondary

MeasureTime frameDescription
Circum-annual rhythms of fractures and the multidimensional profiles of patients by age groupEntire study duration, approximately 5 yearsAnalyze the circum-annual rhythms of fractures and the multidimensional profiles (clinical, functional and cognitive) of patients by age group
Improvement of clinical practiceEntire study duration, approximately 5 yearsProgressively direct all the centers participating in the study towards the principles of orthogeriatric good clinical practice, periodically analyzing their performances and comparing them with those established as optimal by the international scientific literature; in this perspective, the study can be configured as a quality improvement project. In fact, the multidisciplinary discussion and comparison that will follow the systematic review of the indicators analyzed will stimulate, as has already happened elsewhere (e.g. in the United Kingdom), a process of continuous improvement of clinical and surgical practices.
Improvement of collaboration of specialists from various disciplinesEntire study duration, approximately 5 yearsActively involve specialists from various disciplines who are currently engaged in an uncoordinated way in the management of these patients and seek synergies with other potentially interested companies (eg Italian Society of Anesthesiology)
Increase the sensitivity of doctors and operators on the problems of the elderly population with hip fracture between participating centersEntire study duration, approximately 5 yearsIncrease the sensitivity of doctors and operators participating in the study and of potential other operators belonging to other centers on the problems of the elderly population with hip fracture, ensuring periodic (half-yearly / annual) a return of information (through general reports and by centers) to participating centers explaining the clinical and management characteristics of patients
Enhance the model of orthogeriatrics and geriatric-orthopedic managementEntire study duration, approximately 5 yearsEnhance the model of orthogeriatrics and geriatric-orthopedic management, through analyzes that study the relationship between the model of care received and clinical outcomes (onset of post-operative complications, recovery of the ability to walk, destination for discharge)

Countries

Italy

Contacts

Primary ContactGiuseppe Belelli, Proff.
giuseppe.bellelli@unimib.it+39/0392339638

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026