Clinical trial · Observational
Virtual Surgical Planning Systems in Mandibular Reconstruction
Evaluation of Virtual Surgical Planning Systems and Customized Devices in Fibula Free Flap Mandibular Recontruction
NCT03869723CI-TRIAL-00037547VP3DcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mandibular Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional surgery | Procedure | — | UNRESOLVED |
| Virtual planning using customized surgical devices | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Conventional surgery
- description
- Classical surgery for mandibular reconstruction with fibula free flap
- interventionNames
- Procedure: Conventional surgery
- label
- 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
- interventionNames
- Procedure: Virtual planning using customized surgical devices
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDBlanc J, Fuchsmann C, Nistiriuc-Muntean V, Jacquenot P, Philouze P, Ceruse P. Evaluation of virtual surgical planning systems and customized devices in fibula free flap mandibular reconstruction. Eur Arch Otorhinolaryngol. 2019 Dec;276(12):3477-3486. doi: 10.1007/s00405-019-05625-z. Epub 2019 Sep 9. PMID 31501989