Virtual Surgical Planning Systems in Mandibular Reconstruction

Study Overview
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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.

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

Conditions
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Mandibular Neoplasms

Intervention / Treatment
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* Procedure: Virtual planning using customized surgical devices
* Procedure: Conventional surgery


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional surgery<br>Classical surgery for mandibular reconstruction with fibula free flap | Procedure: Conventional surgery<br>* Classical surgery for mandibular reconstruction with fibula free flap<br>|
| Virtual planning<br>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 | Procedure: Virtual planning using customized surgical devices<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes | 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. | Six months after surgery |