跳至主要内容
临床试验/NCT03152916
NCT03152916Unknown不适用

Application of 3D Printing Technology in Subtalar 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 aims to use 3D printing personalized plate to locate the position in which the K-wires would be drilled to save operation time and decrease the number of times that the K-wires are drilled.

详细描述

Subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. In this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. During the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm Kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the Kirschner wires are confirmed under the C-arm; lastly, cannulated screws are screwed in along the Kirschner wires for effective fixation.

In the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the C-arm. This would prolong the operation time and be more traumatic to the patients. Using 3D printing personalized plate can solve this problem.

The preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's CT scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. Apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm Kirschner wires with the guidance of the plate. If the locations of the fusion joint and the Kirschner wires are satisfying under the C-arm inspection, drill the hollow screw 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 subtalar arthrodesis and consider internal fixation with screws

排除标准

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

研究组 & 干预措施

3D printing personalized plate

Experimental

3D printing personalized plate will be used to guide the Kirschner wires in the joint fusion surgery.

干预措施: 3d printing personalized 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 subtalar VAS score(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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