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临床试验/NCT03757286
NCT03757286Unknown不适用

Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using Free Scapular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)

Cairo University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
试验地点
1
主要终点
Aesthetic

研究概览

简要总结

The aim of the study is to compare aesthetic results and operation time of Free Scapular flap with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.

详细描述

Maxillofacial defects create unique challenges for the reconstructive surgeon, often involving bony and soft tissue components of the midface. Surgical reconstruction following maxillectomy is currently a topic of interest for reconstructive head and neck surgeons. maxillary defects were reconstructed with maxillofacial prosthetics including obturation. While the latter is an effective reconstruction. Over the past two decades, there has been increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.

Scapular flap It is an excellent candidate for maxillectomy defects because of its unique feature, which is characterized by additional skin paddles or muscles. and can be harvested along with a part of the scapular bone for bony reconstruction

Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact planning, poor communication between the resective and reconstructive teams or surgical difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D) defect without the help of any templates or surgical guides The advent of 3D modeling in head and neck reconstruction has allowed surgeons to improve upon functional and aesthetic outcomes, which are crucial to patient satisfaction and can be difficult to achieve in maxillectomy defects The cutting guides used or not used, however debate still present for its benefits and worth for patient and surgeon. current study to evaluate how such virtual planning with using of customized cutting guide is effective and worth for patient aesthetic and operation time.

our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing maxillary reconstruction using free scapular flap.

In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results of another group of patients receive FSF but without customized osteotomy guide. only model will be performed as conventional method aiding in reshaping of reconstruction plate which is another well-established concept of management of maxillary defect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients affected by tumor involving Maxillary bone.

排除标准

  • Patients having poor oncological prognosis
  • Patients with poor performance status together with other relative or absolute vascular contraindication.

研究组 & 干预措施

FSF with CAD\CAM customized cutting guide

Experimental

Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide.

干预措施: FSF with CAD\CAM customized cutting guide (Procedure)

FSF without customized cutting guide

Active Comparator

maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used.

干预措施: FSF without customized cutting guide (Procedure)

结局指标

主要结局

Aesthetic

时间窗: at least three months postoperative

aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to other side of maxilla.subjectively will be evaluated using VAS.

次要结局

  • operation time(intraoperative)

研究者

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

Mohammed Salah Mohammed Al-Wadeai

principal investigator

Cairo University

研究点 (1)

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