Virtual Surgical Planning Systems in Mandibular Reconstruction (VP3D)

Civil Hospices of Lyon

Status: Completed

Conditions: Mandibular Neoplasms

Treatments: Procedure: Conventional surgery; Procedure: Virtual planning using customized surgical devices

Study type: Observational

Funder types: Other

Identifiers

NCT03869723

CRC_GHN_2019_002

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 2 patient groups

Conventional surgery

Description:

Classical surgery for mandibular reconstruction with fibula free flap

Treatment:

Procedure: Conventional surgery

Virtual planning

Description:

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

Treatment:

Procedure: Virtual planning using customized surgical devices