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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05150249
Other study ID # GIOG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date August 31, 2024

Study information

Verified date January 2023
Source University of Milano Bicocca
Contact Giuseppe Belelli, Proff.
Phone +39/0392339638
Email giuseppe.bellelli@unimib.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 the principles of good clinical practice in orthogeriatrics.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 7000
Est. completion date August 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Ospedale S. Agostino Estense Baggiovara
Italy Policlinico S.Orsola-Malpighi Bologna
Italy Ospedale Centrale di Bolzano Bolzano
Italy ASST Vimercate - Ospedale di Carate Brianza Carate Brianza
Italy Arcispedale Sant'Anna Ferrara
Italy A.O.U. di Careggi Firenze
Italy Azienda Usl Toscana centro Firenze
Italy Ospedale Galliera Genova Genova
Italy Ospedale Policlinico S. Martino Genova
Italy Policlinico Universitario Campus Bio-Medico Roma
Italy ASST della Valtellina e dell'Alto Lario Sondrio

Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Entire study duration, approximately 5 years
Secondary 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. Entire study duration, approximately 5 years
Secondary 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) Entire study duration, approximately 5 years
Secondary 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 Entire study duration, approximately 5 years
Secondary 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) Entire study duration, approximately 5 years
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