跳至主要内容
临床试验/NCT06448325
NCT06448325招募中不适用

RIFRA - Re-fracture Risk Prediction in Patients With Fragility Fracture: Score Development and Validation

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
1
主要终点
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)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

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)

时间窗: Baseline: the outcomes are assessed before surgery

Patient characteristics and comorbidities associated with a fragility fracture of the hip

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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