Shenzhen Hospital of Southern Medical University
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- operative time
研究概览
简要总结
Objective: Clinical application of 3D printing implant in bone defect treatment.
Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Open fracture with bone defect
- •Burst fracture of spine with bone defect
- •Bone tumor with bone defect
- •Bone tuberculosis with bone defect
- •Nonunion with bone defect
排除标准
- •Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
- •Systemic or local infection
研究组 & 干预措施
3D printing implant
3D printing implant in bone defect
干预措施: 3D printing implant (Procedure)
Autogenous bone grafting
autogenous bone grafting in bone defect
干预措施: autogenous bone grafting (Procedure)
结局指标
主要结局
operative time
时间窗: 3 years
次要结局
未报告次要终点
研究者
fang guofang
Shenzhen Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University