Virtual Surgical Planning Systems in Mandibular Reconstruction

Completed

• Conditions: Mandibular Neoplasms
• Interventions: Procedure: Virtual planning using customized surgical devices; Procedure: Conventional surgery

• Registration Number: NCT03869723
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2017-11-30
• Study Completion: 2018-03-31
• Study First Submitted: 2019-02-08
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who underwent fibula free flap for mandibular reconstruction
• Patient ≥18 years old
• patient alive 6 months after completion of treatment

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Exclusion Criteria

• Patient without post-operative scan evaluation
• Patient with a chirurgical contraindication
• Pregnant or nursing woman
• Adult requiring protection (guardianship, supervision)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Virtual planning	Virtual planning using customized surgical devices	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
Conventional surgery	Conventional surgery	Classical surgery for mandibular reconstruction with fibula free flap

Primary Outcome Measures

Name	Time	Method
Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes	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.

Trial Locations

Locations (1)

Croix-Rousse Hospital - Hospices Civils de Lyon; 🇫🇷 Lyon, France