HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,440
- 试验地点
- 26
- 主要终点
- Composite variable comprising reoperation rate and mortality
研究概览
简要总结
A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).
详细描述
The aim of this study is to determine whether the treatment of elderly patients with an undisplaced femoral neck fracture (uFNF) can be improved by decreasing reoperation rates through replacing the hip instead of trying to preserve it. Patients ≥75 years with an uFNF will be included and randomized within the Swedish Fracture Register (SFR) platform to internal fixation (screws/pins) or arthroplasty (choice of hemi or total is at the surgeon's discretion). The primary outcome will be a composite variable that combines two variables (reoperations and mortality) into a single variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undisplaced (Garden I-II) femoral neck fracture (within 72h)
- •treated at participating unit
- •informed consent
- •amenable for both treatment options
排除标准
- •no informed consent
- •pathological or stress fracture
- •peri-implant fracture
结局指标
主要结局
Composite variable comprising reoperation rate and mortality
时间窗: 1 to 2-year post-surgery
Both Death and mortality will be accounted for
次要结局
- Reoperation rate(2-year post-surgery)
- Short-term Mortality(30 day mortality)
- Long-term Mortality(2-year post-surgery)
- Patient reported outcome: SMFA(1-year post surgery)