NCT04965441

CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap

Computer-assisted Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap: A Matched-pair Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups.

Conditions

• Operation Time
• Complication of Surgical Procedure

Interventions

Type	Name	Description
PROCEDURE	Computer-assisted surgery	Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness\<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-03-01
• Completion: 2021-04-18
• First posted: 2021-07-16
• Last updated: 2021-07-21

Locations

1 site across 1 country: Belgium