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Virtual Surgical Planning Systems in Mandibular Reconstruction

NCT03869723 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-03-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2017-11-30
Completion
2018-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869723 on ClinicalTrials.gov