跳至主要内容
临床试验/NCT04895319
NCT04895319已完成不适用

Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions

KU Leuven0 个研究点目标入组 136 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
136
主要终点
The adherence of computer-assisted surgery

研究概览

简要总结

The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.

详细描述

computer-aided design

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models.
  • Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis.

排除标准

  • Patients undergoing computer-assisted implant surgery were excluded.
  • Patients undergoing computer-assisted orthognathic surgery were excluded.

结局指标

主要结局

The adherence of computer-assisted surgery

时间窗: The outcome were recorded preoperatively or intraoperatively

The original plans were classified as completely executed, partially executed or abandoned.

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongyang Ma

Principle investigator

KU Leuven

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