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Clinical Trials/NCT05150249
NCT05150249
Recruiting
Not Applicable

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

University of Milano Bicocca11 sites in 1 country7,000 target enrollmentJuly 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
University of Milano Bicocca
Enrollment
7000
Locations
11
Primary Endpoint
Compare the management and clinical methods
Status
Recruiting
Last Updated
9 months ago

Overview

Brief 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.

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)

Registry
clinicaltrials.gov
Start Date
July 15, 2019
End Date
December 31, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Improvement of clinical practice(Entire study duration, approximately 5 years)
  • Enhance the model of orthogeriatrics and geriatric-orthopedic management(Entire study duration, approximately 5 years)
  • Improvement of collaboration of specialists from various disciplines(Entire study duration, approximately 5 years)
  • Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group(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(Entire study duration, approximately 5 years)

Study Sites (11)

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