Evaluation of Virtual Surgical Planning Systems and Customized Devices in Fibula Free Flap Mandibular Recontruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mandibular Neoplasms
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
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.