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NCT Number: NCT05150249

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

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.

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Key information

Conditions

Hip Fractures Comprehensive Geriatric Assessment Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Older Patients Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale S. Agostino Estense, Baggiovara, Italy

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Circum-annual rhythms of fractures and the multidimensional profiles of patients by age group

    Time frame: Entire study duration, approximately 5 years

    Analyze the circum-annual rhythms of fractures and the multidimensional profiles (clinical, functional and cognitive) of patients by age group

  2. Improvement of clinical practice

    Time frame: Entire study duration, approximately 5 years

    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.

  3. Improvement of collaboration of specialists from various disciplines

    Time frame: Entire study duration, approximately 5 years

    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)

  4. 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

    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

  5. Enhance the model of orthogeriatrics and geriatric-orthopedic management

    Time frame: Entire study duration, approximately 5 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Belelli, Proff.

CONTACT

[email protected]

+39/0392339638

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Acronym: GIOG

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2021
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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