NCT04725396

Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC

A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a national multicenter, randomized, stratified, open label study, aiming to compare mandibular reconstruction (MR) with or without preoperative virtual planning (PVP), in patients with oral/oropharyngeal cancer (OOPC).

Detailed description

PVP-assisted MR includes the production of the surgical cutting guides required for mandibular resection and fibula free-flap conformation and of the preformed plates for flap osteosynthesis (for all patients, PVP will be done by the same laboratory: Materialise laboratory). PVP-assisted MR includes the production of : * surgical cutting guides required for mandibular resection and fibula free-flap conformation * preformed plates for flap osteosynthesis Patients will be selected after the multidisciplinary decision of oncological surgery including segmental mandibulectomy and immediate MR. Patients will be randomized in 2 groups (ratio 1:1, stratified on center and tumor N status \[0-1 vs 2-3\]).

Conditions

• Oropharynx Squamous Cell Carcinoma
• Oral Cavity Squamous Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Mandibular Reconstruction (MR) with Preoperative Virtual Planning (PVP).	PVP-assisted mandibular reconstruction includes the production of the surgical cutting guides required for mandibular resection and fibula free-flap conformation and of the preformed plates for flap osteosynthesis (for all patients, PVP will be done by the same laboratory).
DEVICE	Conventional Mandibular Reconstruction (MR without PVP)	Conventional Mandibular Reconstruction

Timeline

• Start date: 2021-04-20
• Primary completion: 2025-10-15
• Completion: 2025-10-15
• First posted: 2021-01-26
• Last updated: 2025-11-20

Locations

10 sites across 1 country: France