3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
Chongqing
-
Chongqing、Chongqing、中国、400030
- 招聘中
- Southwest Hospital
-
接触：
- Xiaojun Duan, MD
- 电话号码：86-23-68765290
- 邮箱：duanxiaojun@hotmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Receive ankle or subtalar arthrodesis;
- Refuse to use autologous bone graft or allogeneic bone graft.
Exclusion Criteria:
- The local defect area is small;
- Refuse to use permanent metal metal implant.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：3D-printed personalized metal implant
3D-printed personalized metal implant will be used in bone defect surgeries.
|
3d-printed personalized metal implant will be used in subtalar arthrodesis.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual Analogue Scale (VAS)
大体时间：Postoperative 24 months
|
The decrease in VAS score from baseline
|
Postoperative 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
大体时间：Postoperative 24 months
|
The increase in AOFAS score from baseline
|
Postoperative 24 months
|
|
Lower limb alignment
大体时间：Postoperative 24 months
|
Analyze the lower limb alignment by radiography
|
Postoperative 24 months
|
|
Osteotylus growth
大体时间：Postoperative 24 months
|
Analyze the osteotylus growth by radiography
|
Postoperative 24 months
|
|
Implant displacement
大体时间：Postoperative 24 months
|
Assess the implant displacement by radiography
|
Postoperative 24 months
|
合作者和调查者
调查人员
- 首席研究员：Xiaojun Duan, MD、Southwest Hospital, China
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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