Improved implant for reconstruction purposes after mandibular resectio

Completed

• Conditions: Head and Neck Cancer; Oral cavity tumour; Tumour with mandible invasion; 10027655; 10019190

• Registration Number: NL-OMON50065
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Age >= 18 years at time of study entry.
• T4 oral cavity tumor with mandible invasion, requiring segmental
mandibulectomy.
• Reconstruction with free fibula flap not feasible because of any or a
combination of the following reasons::
o CT angiography of the legs and/or the neck shows severe stenosis of the
ves-sels.
o Previous medical history of severe atherosclerotic disease.
o General health condition necessitating a shorter operation time.
• Cases will be discussed in the multidisciplinary tumor board that they are
eligible for composite resection but not eligible for free fibula flap.
• Written informed consent.

Exclusion Criteria

• Patients who are eligible for free fibula flap.
• Pregnancy.
• General health condition does not allow surgery
• History of psychiatric disability judged by the investigator to potentially
hamper compliance with the study protocol and follow-up schedule.
• Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study endpoint is to use the RIfRaM without any complications and a perfect<br /><br>mandibular fit. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Opinions of the surgeons using the implant will be collected in a<br /><br>non-structured form.</p><br>