Plate Fixation Versus Percutaneous Cannulated Screw Insertion in Sanders Type II and Type III Calcaneal Fractures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bohler Angle
研究概览
简要总结
Sanders Ⅱ and Ⅲ intra-articular calcaneal fractures primarily result from falls from height, often accompanied by severe flap soft tissue injury and notable displacement of fracture fragments, which can pose significant reconstruction challenges. The traditional "L" lateral incision open reduction and internal fixation technique is considered the gold standard for the surgical treatment of calcaneal fractures. This trial aims to demonstrate that Percutaneous Cannulated Screws are not inferior to open reduction and internal fixation (ORIF) with plates in the treatment of calcaneal fractures.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with calcaneal fractures according to Sanders classification are Sanders type II or type III.
- •Closed calcaneal fracture.
- •Patients aged 18-60.
排除标准
- •Patients with calcaneal fractures classified as Sanders type I or IV.
- •Open calcaneal fractures.
- •Patients with systemic comorbidities preventing surgical intervention (unfit patients).
- •Patients younger than 18 years old or older than
- •Patients with associated spinal fractures.
- •Patients with other fractures in the same limb.
研究组 & 干预措施
Percutaneous Cannulated Screws
干预措施: percutaneous cannulated screw fixation (Procedure)
Plate Fixation
Fixation of calcaneal fracture by plate
干预措施: Plate fixation (Procedure)
结局指标
主要结局
Bohler Angle
时间窗: Preoperative, immediate postoperative, and at 6 months.
Gissane Angle
时间窗: Preoperative, immediate postoperative, and at 6 months.
AOFAS Score
时间窗: At 6 months.
Calcaneal width
时间窗: Preoperative, immediate postoperative, and at 6 months.
Calcaneal height
时间窗: Preoperative, immediate postoperative, and at 6 months.
Calcaneal length
时间窗: Preoperative, immediate postoperative, and at 6 months.
Surgical time
时间窗: intra-operative
次要结局
- Time to union(at radiological evidence of healing, in 6 weeks.)
- Subtalar Arthritis(At 6 months.)
- Complication Rate(At 6 months.)