Virtual Surgical Planning Systems in Mandibular Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mandibular Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Conventional surgery

Classical surgery for mandibular reconstruction with fibula free flap

Conventional surgery

Intervention Type PROCEDURE

Classical surgery for mandibular reconstruction with fibula free flap

Virtual planning

Fibula free flap in mandibular reconstruction using preoperative virtual planning, cutting guides and osteosynthesis plates. Preoperative modeling was conducted by obtaining scans of patient maxillofacial skeleton and angioscans of the lower extremities. The planning phase was then carried out by the surgeon and the engineer (from MATERIALISE, Leuven, Belgium) so as to define the clinical and technical parameters of the reconstruction. This stage consisted of discussing and determining osteotomy lines, donor side, anastomosis site, and overall reconstruction contour. Resection was decided by the surgeon. 3D modeling and the manufacture of cutting guides and customized osteosynthesis plates were then undertaken

Virtual planning using customized surgical devices

Intervention Type PROCEDURE

Preoperative modeling was conducted by obtaining scans of patient maxillofacial skeleton and angioscans of the lower extremities. The planning phase was then carried out by the surgeon and the engineer (from MATERIALISE, Leuven, Belgium) so as to define the clinical and technical parameters of the reconstruction. This stage consisted of discussing and determining osteotomy lines, donor side, anastomosis site, and overall reconstruction contour. Resection was decided by the surgeon. 3D modeling and the manufacture of cutting guides and customized osteosynthesis plates were then undertaken

Interventions

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Virtual planning using customized surgical devices

Preoperative modeling was conducted by obtaining scans of patient maxillofacial skeleton and angioscans of the lower extremities. The planning phase was then carried out by the surgeon and the engineer (from MATERIALISE, Leuven, Belgium) so as to define the clinical and technical parameters of the reconstruction. This stage consisted of discussing and determining osteotomy lines, donor side, anastomosis site, and overall reconstruction contour. Resection was decided by the surgeon. 3D modeling and the manufacture of cutting guides and customized osteosynthesis plates were then undertaken

Intervention Type PROCEDURE

Conventional surgery

Classical surgery for mandibular reconstruction with fibula free flap

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No