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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06448325
Other study ID # RIFRA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 28, 2024
Est. completion date February 28, 2025

Study information

Verified date June 2024
Source I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date February 28, 2025
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Italy IRCCS Ospedale Galeazzi-Sant'Ambrogio Milan Italia

Sponsors (1)

Lead Sponsor Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Age, sex, disease name and body mass index (weight in kg and height in m will be combined to report BMI in kg/m^2) Patient characteristics and comorbidities associated with a fragility fracture of the hip Baseline: the outcomes are assessed before surgery
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