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临床试验/NCT03054012
NCT03054012已完成不适用

Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region

AZ Sint-Jan AV0 个研究点目标入组 30 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
accuracy of planned and actual result, through segmentation of mandibles Brainlab software

研究概览

简要总结

Background:

Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication.

Study design:

Retrospective study.

All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients of all ages
  • patients of both genders
  • patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma
  • all patients undergoing bony reconstruction by free vascularised flap
  • all patients treated between January 2013 and August 2016
  • all patients where CAS was applied

排除标准

  • all patients not eligible according to abovementioned criteria

结局指标

主要结局

accuracy of planned and actual result, through segmentation of mandibles Brainlab software

时间窗: 6 months postoperative

次要结局

  • financial implication(preoperative)
  • ischemia time(perioperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Johan Abeloos

head of department

AZ Sint-Jan AV

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