Virtual Surgical Planning Systems in Mandibular Reconstruction

Mandibular Neoplasms Clinical Trial

— VP3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869723
• Other study ID #: CRC_GHN_2019_002
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mandibular Neoplasms

Intervention

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
• Conventional surgery
Classical surgery for mandibular reconstruction with fibula free flap

Locations

Country	Name	City	State
France	Croix-Rousse Hospital - Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes	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.	Six months after surgery