Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32,953
- 主要终点
- Surgical complications during index case
研究概览
简要总结
The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.
详细描述
see Protocol
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients will be included, who had an inpatient coded treatment using LPF or RTSA
排除标准
- •Incomplete insurance status within two years before index
- •Incomplete basic information
- •Age<65 years
- •Missing diagnosis of PHF (ICD: S42.2) within two years before surgery
- •Previous surgical treatment (RTSA, LPF or other fracture fixation)
- •Coded polytrauma
- •Bone tumors/ bone metastasis
- •Both sides or missing information of surgery side
- •COVID-19 infection during index hospitalization
结局指标
主要结局
Surgical complications during index case
时间窗: through hospital stay, an average of 16 days
See above, only events during hospitalization
30-day mortality
时间窗: 30 days
Death from any cause during the first 30-days after surgery.
Overall survival (OS)
时间窗: up to 12 years
Time from discharge of index hospitalization to death of any case.
Major adverse events during index case
时间窗: through hospital stay, an average of 16 days
See above, only events during hospitalization
Major adverse events after discharge
时间窗: up to 12 years
Time from discharge of index hospitalization to MAE as defined above
Thromboembolic events during index
时间窗: through hospital stay, an average of 16 days
See above, only events during hospitalization
Thromboembolic events (or death) after discharge
时间窗: up to 12 years
Time from discharge of index hospitalization to a thromboembolic event or death of any case.
Surgical complications after discharge
时间窗: up to 12 years
Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.
次要结局
- Implant-associated complication during index(through hospital stay, an average of 16 days)
- Non-Implant-associated complication during index(through hospital stay, an average of 16 days)
- Minor outpatient complications after discharge(up to 12 years)
研究者
Prof. Dr. med. J. Christoph Katthagen
Senior Consultant
University Hospital Muenster