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Virtual Surgical Planning Systems in Mandibular Reconstruction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03869723
Acronym
VP3D
Enrollment
30
Registered
2019-03-11
Start date
2017-11-01
Completion date
2018-03-31
Last updated
2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Neoplasms

Brief 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.

Interventions

PROCEDUREVirtual 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

PROCEDUREConventional surgery

Classical surgery for mandibular reconstruction with fibula free flap

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the cephalometrics measurements between the virtual model and postoperative outcomesSix months after surgeryThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026