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

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965441
• Other study ID #: S63615-2
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: April 18, 2021

Study information

• Verified date: July 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 18, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Operation Time

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	operation time	within the surgery