Fragility Re-fractures Prediction Score

NCT06448325 | Recruiting

• 1 other identifier: RIFRA
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis Risk

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Hip arthroplasty OTHER

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 60 or more, of all sexes.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italia, 20157, Italy

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: May 28, 2024
• Primary Completion: October 31, 2024
• Study Completion: February 28, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

IT (1)