Virtual Surgical Planning Systems in Mandibular Reconstruction
- Conditions
- Mandibular Neoplasms
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Patients who underwent fibula free flap for mandibular reconstruction
- Patient ≥18 years old
- patient alive 6 months after completion of treatment
- Patient without post-operative scan evaluation
- Patient with a chirurgical contraindication
- Pregnant or nursing woman
- Adult requiring protection (guardianship, supervision)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Croix-Rousse Hospital - Hospices Civils de Lyon
🇫🇷Lyon, France
Croix-Rousse Hospital - Hospices Civils de Lyon🇫🇷Lyon, France