Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hip Fractures, Older Patients, Comprehensive Geriatric Assessment. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Primary outcome measures
- Compare the management and clinical methods [Time frame: Entire study duration, approximately 5 years]
Secondary outcome measures (5)
- Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group [Time frame: Entire study duration, approximately 5 years]
- Improvement of clinical practice [Time frame: Entire study duration, approximately 5 years]
- Improvement of collaboration of specialists from various disciplines [Time frame: 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 [Time frame: Entire study duration, approximately 5 years]
- Enhance the model of orthogeriatrics and geriatric-orthopedic management [Time frame: Entire study duration, approximately 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 11 centers
- Ospedale S. Agostino Estense — Baggiovara
- Policlinico S.Orsola-Malpighi — Bologna
- Ospedale Centrale di Bolzano — Bolzano
- ASST Vimercate - Ospedale di Carate Brianza — Carate Brianza
- Arcispedale Sant'Anna — Ferrara
- A.O.U. di Careggi — Florence
- Azienda Usl Toscana centro — Florence
- Ospedale Galliera Genova — Genova
- … and 3 more centers
Identifiers
NCT: NCT05150249 · GIOG