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临床试验/NCT03626935
NCT03626935Unknown不适用

3D Printed Customized Guide in Ankle Arthrodesis

Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Operation time

研究概览

简要总结

This study applies 3D-printed customized guide plate in assisting the accurate drilling of Kirschner wire in ankle arthrodesis. This technique can shorten the operation time, reduce the intra-operative radiation, and do not affect the surgical outcome.

详细描述

Ankle arthrodesis is the standard procedure for treating end-stage joint diseases. In order to improve the surgical outcome and reduce the operation time, 3D-printed customized guide plates are fabricated using patients' ankle DICM data of ankle via CT examinations. Two 2mm Kirschner wires are drilled with the help of the guides; the C-arm fluoroscopy is used to confirm the position of the wires before applying the cannulated screws for effective fixation.

In the past when there were no customized guides, the surgeons would drill the Kirschner wire according to his/her previous experience and then use C-arm fluoroscopy to confirm whether the position of the wire is satisfactory; if not, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem is well solved by applying the 3D-printed customized guides.

The application procedure for the customized guide plates: the model of the ankle joint is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. Apply routine surgical treatment to the ankle joint surface, reset the fusion joint to the functional position, and drill two 2mm Kirschner wires with the guidance of the guide plate. If the locations of the fusion joint and the Kirschner wires are satisfactory under the C-arm fluoroscopy, drill the cannulated screws for final fixation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
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

入选标准

  • Patients who receive ankle arthrodesis and consider internal fixation with screws

排除标准

  • Patients who receive ankle arthrodesis but do not consider internal fixation with screws

研究组 & 干预措施

3D-printed customized guide plate

Experimental

3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis.

干预措施: 3D-printed customized guide plate (Device)

结局指标

主要结局

Operation time

时间窗: Intraoperative

Operation time for internal fixation

次要结局

  • Fusion rate(Postoperative 1,6,12 months)
  • Postoperative ankle AOFAS scale(Postoperative 1,6,12 months)

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaojun Duan

Deputy Director of the Center for Joint Surgery

Southwest Hospital, China

研究点 (1)

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