Hip Fractures Clinical Trial
— GIOGOfficial title:
Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
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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