NCT06172179招募中不适用
Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- secondary vertebral fractures
研究概览
简要总结
"Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures."
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022);
- •No history of high-energy trauma;
- •Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2);
- •Has undergone Percutaneous Vertebroplasty (PVA) treatment.
排除标准
- •Incomplete imaging or medical record data;
- •History of spinal surgeries other than PVA;
- •Pre-existing symptoms of spinal cord compression or nerve root injury;
- •Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes;
- •Chronic conditions like Kummell's disease or non-union of old fractures;
- •Concurrent vertebral burst fractures;
- •Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure;
- •History of violent trauma after PVA procedure.
结局指标
主要结局
secondary vertebral fractures
时间窗: 2 years post-operative
Recording the secondary vertebral fractures
次要结局
未报告次要终点
研究者
研究点 (1)
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