Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group

Hip Fractures Clinical Trial

— GIOG  

Official title:

Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150249
• Other study ID #: GIOG
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Comprehensive Geriatric Assessment
• Fractures, Bone
• Hip Fractures
• Older Patients

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