3D printing assisted reduction and internal fixation for calcaneal fractures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Operative time (in minutes) for surgical fixation of intra-articular calcaneal fractures
研究概览
简要总结
Traditionally surgery for calcaneal fracture is usually performed after preoperative planning based on X-ray and CT, which give only a limited understanding of the fracture patterns. With the 3D printing technology becoming more accessible technically and financially, it has been widely used in the field of orthopedics, allowing preoperative planning of the surgical approach on the 3D model including the reproduction of the design and size of the hardware that would be used for osteosynthesis during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients with acute, closed, displaced, Sanders type II, III or IV unilateral or bilateral calcaneal fracture without associated ipsilateral lower limb injury.
排除标准
- •1.Patients with previous history of ankle or foot surgery.
- •2.Pathological fractures, open fractures, severe soft tissue injuries (Tscherne and Oestern closed grade II and grade III).
- •3.Patients with existing ipsilateral ankle or foot deformity.
- •4.Patients not giving consent for the study.
结局指标
主要结局
Operative time (in minutes) for surgical fixation of intra-articular calcaneal fractures
时间窗: Measured intraoperatively at the time of surgery for each patient (single time point)
次要结局
- Number of intraoperative fluoroscopy exposures (C-arm shots) used during fixation of calcaneal fractures(Measured intraoperatively during the surgery for each patient (single time point))
- Radiographic parameters – Böhler’s angle, Gissane’s angle, calcaneal height, & calcaneal width(Immediately postoperative (within 1 week after surgery) & at final follow-up (6 months postoperatively))
- Functional outcome evaluated by the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle–Hindfoot Score & Visual Analogue Scale (VAS) for pain(At 6 weeks, 3 months, & 6 months postoperatively)
研究者
Asjad Mahmood
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi