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

NCT04965441 | Completed

• 1 other identifier: S63615-2
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Operation Time; Complication of Surgical Procedure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• operation time

  operation time

  within the surgery

Study Arms (2)

Computer-assisted surgery (CAS) group

Procedure: Computer-assisted surgery

Non-CAS group

Interventions

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.

Computer-assisted surgery (CAS) group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019.

You may qualify if:

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

You may not qualify if:

• Patients received bone graft for jaw reconstruction before mandibular reconstruction

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Interventions

Surgery, Computer-Assisted

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 18, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)