Head and Neck Cancer Oral cavity tumour Tumour with mandible invasion
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study endpoint is to use the RIfRaM without any complications and a perfect mandibular fit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Opinions of the surgeons using the implant will be collected in a non-structured form. | — |
Countries
Netherlands
Outcome results
None listed