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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04965441

Enrollment

153

Registered

2021-07-16

Start date

2020-12-01

Completion date

2021-04-18

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Surgical Procedure, Operation Time

Keywords

Computer-Assisted Surgeries, Mandibular Reconstruction, Matched-Pair Analysis

Brief 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.

Interventions

PROCEDUREComputer-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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of head and neck cancer * Received mandibular reconstruction * All patients were followed up postoperatively for at least one year

Exclusion criteria

* Patients received bone graft for jaw reconstruction before mandibular reconstruction

Design outcomes

Primary

Measure	Time frame	Description
operation time	within the surgery	operation time

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026