Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Non-operative vertebral re-fracture within 1 year after PVP / PKP
研究概览
简要总结
In this project, IDEAL-IQ technology and PDFF and R2* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the Osteoporotic Fractures Guidelines (2022 edition);
- •The presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by MR examination, and the responsible vertebrae is treated with PVP / PKP;
- •Number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures).
排除标准
- •History of severe scoliosis, vertebroplasty, or internal spinal fixation;
- •Presence of spinal infection and malignant neoplastic disease;
- •Presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).
结局指标
主要结局
Non-operative vertebral re-fracture within 1 year after PVP / PKP
时间窗: 1 year
Non-operative vertebral re-fracture within 1 year after PVP / PKP, confirmed by follow-up spinal MRI
次要结局
- Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP(1 year)
- Visual Analog Score (VAS) at 1 year after PVP/ PKP(1 year)
研究者
Qingyu Liu
chief physician
The Seventh Affiliated Hospital of Sun Yat-sen University