Clinical trial NCT05150249: Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
Official title: Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Older Patients
Comprehensive Geriatric Assessment
Keywords: GIOG ( Italian Society of Anesthesiology);
geriatric
orthogeriatric
co-management
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 7000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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)

Eligibility criteria: 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

Primary outcomes:
measure: Compare the management and clinical methods
timeFrame: Entire study duration, approximately 5 years
Secondary outcomes:
measure: Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group
timeFrame: Entire study duration, approximately 5 years
measure: Improvement of clinical practice
timeFrame: Entire study duration, approximately 5 years
measure: Improvement of collaboration of specialists from various disciplines
timeFrame: Entire study duration, approximately 5 years
measure: Increase the sensitivity of doctors and operators on the problems of the elderly population with hip fracture between participating centers
timeFrame: Entire study duration, approximately 5 years
measure: Enhance the model of orthogeriatrics and geriatric-orthopedic management
timeFrame: Entire study duration, approximately 5 years
Other outcomes:
Locations:
city: Baggiovara
country: Italy
facility: Ospedale S. Agostino Estense
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano
city: Carate Brianza
country: Italy
facility: ASST Vimercate - Ospedale di Carate Brianza
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna
city: Firenze
country: Italy
facility: A.O.U. di Careggi
city: Firenze
country: Italy
facility: Azienda Usl Toscana centro
city: Genova
country: Italy
facility: Ospedale Galliera Genova
city: Genova
country: Italy
facility: Ospedale Policlinico S. Martino
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Sondrio
country: Italy
facility: ASST della Valtellina e dell'Alto Lario
Study officials:
References: