Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 162
- 主要终点
- Primary efficacy hypothesis
研究概览
简要总结
Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic fracture in order to decide on preventive fixation vs follow-up constitute the study population. The patients will be randomized in two arms. First arm - the decision of treatment will rely on conventional decision algorithm including specialist judgement and Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of bone structure and quantitative simulation-based estimate of fracture risk, in addition to the conventional decision algorithm. Operation rates, pathologic fracture rates and additional secondary outcomes will be compared between the two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic bone disease of femur
- •Patients who undergo a CT scan (soft tissue kernel/filter, 120 kVp), and have at least 2/3 of both femurs visible in the CT scan. If CT scan is performed at the Sourasky medical center it must be according to the protocol in Appendix A.
排除标准
- •Ipsilateral previous surgery with or without implants
- •Low quality CT scan or CT does not include at least 2/3 of the femurs.
- •History of fractures, radiation or surgeries in lower limbs.
- •Inability to provide informed consent
研究组 & 干预措施
CTFEA
Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA
干预措施: CTFEA (Diagnostic Test)
Mirels
Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score
干预措施: Conventional decision algorithm (Other)
结局指标
主要结局
Primary efficacy hypothesis
时间窗: four years
To compare proportion of patients undergoing surgery in the treatment group vs the control group.
次要结局
- Composite endpoint(4 months)