Fragility Re-fractures Prediction Score

NCT ID: NCT06448325

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-28

Study Completion Date

2025-02-28

Brief Summary

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Fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure.

Osteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. Even after that, further fractures do occurr, as osteoporosis is often untreated. Several programs have been introduced worldwide to prevent secondary fractures among the population at risk (e.g., International Osteoporosis Foundation's Capture the Fracture), and several risk factors are being investigated to generate a predictive score. However, accurate validation is needed to make these scores reliable.

In this retrospective observational study, we aim to validate a predictive score trained on a population of elderly patients with a cohort of patients who underwent hip fracture surgery in a high-volume orthopedic center in the Region of Lombardy.

Detailed Description

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Conditions

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Osteoporosis Risk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Hip arthroplasty

Surgical treatment of the hip after osteoporosis fracture. The focus of the study is the prediction of further fractures (and therefore further surgical procedures) after the first one.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People who underwent total or partial hip replacement (ICD 9 CM 81.51, 81.52) in five years (2013-2017) at the hospital for a compound fracture of the hip (ICD 9 CM 820, 820.01-820.09).

Exclusion Criteria

* People undergoing the same intervention for other reasons (e.g. pathological fracture, ICD 9 CM 733.14).

ICD 9 CM stands for International Classification of Disease, 9th Revision, Clinical Modification.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italia, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Susan Bernareggi

Role: primary

0039 0226432911

Other Identifiers

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RIFRA

Identifier Type: -

Identifier Source: org_study_id

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