NCT03869723

Virtual Surgical Planning Systems in Mandibular Reconstruction

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mandibular Neoplasms

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	Conventional surgery	Classical surgery for mandibular reconstruction with fibula free flap

Timeline

• Start date: 2017-11-01
• Primary completion: 2017-11-30
• Completion: 2018-03-31
• First posted: 2019-03-11
• Last updated: 2019-03-12

Locations

1 site across 1 country: France