3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.
详细描述
Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.
The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.
Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receive ankle or subtalar arthrodesis;
- •Refuse to use autologous bone graft or allogeneic bone graft.
排除标准
- •The local defect area is small;
- •Refuse to use permanent metal metal implant.
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Postoperative 24 months
The decrease in VAS score from baseline
次要结局
- Osteotylus growth(Postoperative 24 months)
- Implant displacement(Postoperative 24 months)
- Lower limb alignment(Postoperative 24 months)
- American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale(Postoperative 24 months)
研究者
Xiaojun Duan
Deputy Director of the Center for Joint Surgery
Southwest Hospital, China