A multi-centre, participant-blinded, randomized, 3-year study to compare the efficacy of Virtual Surgical Planning (VSP) to Freehand Surgery (FHS) on bony union and quality of life outcomes for mandibular reconstruction with fibular and scapular free flaps: study protocol for a randomized phase II/III trial

BMC Cancer. 2025 Feb 27;25(1):358. doi: 10.1186/s12885-025-13505-5.

Abstract

Background: Advanced head and neck malignancies with underlying bony involvement often require aggressive oncological resection of large segments of the oral cavity including the mandible. These patients require vascularized donor osseous free tissue transfer to reconstruct significant defects. Traditionally, the donor bone is harvested on its vascular supply and shaped to the defect in a free hand fashion (FHS). However, virtual surgical planning (VSP) has emerged as a method to optimize reconstructive outcomes and decrease operative time. The goals of this study are to assess superiority of VSP to FHS by comparing bony union rates at 12 months, short and long-term complication rates, reconstruction accuracy, quality of life (QOL), functional outcomes, and economic analysis.

Methods: This is a multicenter phase II/III study randomizing four hundred twenty head and neck patients undergoing mandibulectomy in a 1:1 ratio between VSP and FHS. Intention-to-treat analysis will be performed for patients enrolled but unable to undergo VSP-aided reconstruction. The primary endpoint is bony-union rates at 1 year post-operatively. Secondary outcomes include complication rates, QOL, functional outcomes, and economic burden.

Discussion: This study will provide an assessment of two different surgical approaches to the reconstructive methods of mandible defects using fibular or scapular free flaps on bony-union rates, complications, QOL and economics.

Trial registration: Clinicaltrials.gov identifier: NCT05429099. Date of registration: June 23, 2022. Current version: 1.0 on March 6, 2024.

Keywords: Head and neck cancer; Mandible Reconstruction; Oral cavity; Quality of life; Randomized controlled trial; Virtual Surgical Planning.

Publication types

  • Clinical Trial Protocol
  • Comparative Study

MeSH terms

  • Adult
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Female
  • Fibula / transplantation
  • Free Tissue Flaps* / transplantation
  • Head and Neck Neoplasms* / surgery
  • Humans
  • Male
  • Mandible / surgery
  • Mandibular Reconstruction* / methods
  • Middle Aged
  • Multicenter Studies as Topic
  • Plastic Surgery Procedures* / methods
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Scapula / transplantation
  • Surgery, Computer-Assisted* / methods
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT05429099