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Completed

NCT Number: NCT04965441

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

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.

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Key information

Conditions

Operation Time Complication of Surgical Procedure

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computer-assisted surgery

Procedure

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.

Primary outcomes

  1. operation time

    Time frame: within the surgery

    operation time

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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