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临床试验/NCT03869723
NCT03869723已完成不适用

Evaluation of Virtual Surgical Planning Systems and Customized Devices in Fibula Free Flap Mandibular Recontruction

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes

研究概览

简要总结

The purpose of this study was to evaluate the accuracy of virtual planning using customized surgical devices (VP3D) in fibula free flap mandibular reconstruction. Virtual planning was compared to postoperative scans using cephalometric and three-dimensional (3D) measurements. Operative times of both VP3D and conventional surgery groups were compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent fibula free flap for mandibular reconstruction
  • Patient ≥18 years old
  • patient alive 6 months after completion of treatment

排除标准

  • Patient without post-operative scan evaluation
  • Patient with a chirurgical contraindication
  • Pregnant or nursing woman
  • Adult requiring protection (guardianship, supervision)

结局指标

主要结局

Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes

时间窗: Six months after surgery

The virtual model obtained using preoperative surgical planning will be compared with postoperative outcomes derived from facial bone scans conducted on all VP3D group patients 6 months after surgery (MIMICS INNOVATION suite 2.1 software, MATERIALISE, Leuven, Belgium). The cephalometrics measurements (in mm) between the virtual model and postoperative outcomes will be compared.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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