Virtual Surgical Planning Systems in Mandibular Reconstruction

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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Key information

Conditions

Mandibular Neoplasms Bone Diseases Bone Neoplasms Jaw Diseases Jaw Neoplasms Mandibular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Skull Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Croix-Rousse Hospital - Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual planning using customized surgical devices

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

conventional surgery

Procedure

Classical surgery for mandibular reconstruction with fibula free flap

Primary outcomes

Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes

Time frame: Six months after surgery

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: VP3D

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Mar 11, 2019
Registry last updated: Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed