Hip FracturesGIOGNCT05150249
Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
An observational study of Hip Fractures and Older Patients, run by University of Milano Bicocca at 11 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Older Patients, Comprehensive Geriatric Assessment
- How many people
- 7,000 participants
- Where
- 11 sitesItaly
- Study dates
- 15 Jul 2019to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
Ospedale S. Agostino Estense
Baggiovara
Chiara Mussi, chiara.mussi@unimore.it
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna
Marialia Lunardelli, marialia.lunardelli@aosp.bo.it
- Recruiting
Ospedale Centrale di Bolzano
Bolzano
Albert March, albert.march@asbz.it
- Recruiting
ASST Vimercate - Ospedale di Carate Brianza
Carate Brianza
Giuseppe Castoldi
- Recruiting
Arcispedale Sant'Anna
Ferrara
Amedeo Zurlo, amedeo.zurlo@unife.it
- Recruiting
A.O.U. di Careggi
Florence
Andrea Ungar, aungar@unifi.it
- Recruiting
Azienda Usl Toscana centro
Florence
Enrico Benvenuti, enrico.benvenuti@uslcentro.toscana.it
- Recruiting
Ospedale Galliera Genova
Genova
Alberto Pilotto, alberto.pilotto@galliera.it
- Recruiting
Ospedale Policlinico S. Martino
Genova
Monica Pizzonia, monica.pizzonia@hsanmartino.it
- Recruiting
Policlinico Universitario Campus Bio-Medico
Roma
Raffaele Antonelli, r.antonelli@unicampus.it
- Recruiting
ASST della Valtellina e dell'Alto Lario
Sondrio
Francesco De Filippi, francesco.defilippi@asst-val.it
About this study
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.
Read the 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)
- Keywords
- GIOG ( Italian Society of Anesthesiology);, geriatric, orthogeriatric, co-management
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Entire study duration, approximately 5 years
Secondary outcomes (5)
Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group
Analyze the circum-annual rhythms of fractures and the multidimensional profiles (clinical, functional and cognitive) of patients by age group
Measured: Entire study duration, approximately 5 years
Improvement of clinical practice
Progressively 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.
Measured: Entire study duration, approximately 5 years
Improvement of collaboration of specialists from various disciplines
Actively 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)
Measured: 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
Increase 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
Measured: Entire study duration, approximately 5 years
Enhance the model of orthogeriatrics and geriatric-orthopedic management
Enhance 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)
Measured: Entire study duration, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start15 Jul 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150249
- Sponsor's protocol ID
- GIOG
- Acronym
- GIOG
- Status last verified
- Jul 2025
- First submitted
- 25 Nov 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
- ClinicalTrials.gov ID
- NCT05150249
- Acronym / sponsor ID
- GIOG / GIOG
- Keywords
- GIOG ( Italian Society of Anesthesiology);, geriatric, orthogeriatric, co-management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the management and clinical methods
Time frame: Entire study duration, approximately 5 years
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Older Patients, run by University of Milano Bicocca at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Belelli, Proff. (+39/0392339638, giuseppe.bellelli@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the management and clinical methods (time frame: Entire study duration, approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.