Improved Implant for Reconstruction Purposes After Mandibular Resection
Reason given: End point is reached with 1 implant which is removed within the observation period
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Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT05153733
- Record updated
- 24 July 2024
- Original description
Study design: A single center non-randomized, prospective clinical feasibility study.Read full original descriptionShow less
Study design: A single center non-randomized, prospective clinical feasibility study.
Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction.
Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant.
Objective: The aim is to provide enough evidence through model analysis, physical tests and clinical study of 10 patients that our new type of personalized mandibular implant is safe to use, resulting in significantly fewer complications and can be practically placed during the surgery, without any complications.
Main study parameters/endpoints: The study endpoint is to use the RifRaM without any implant related complications and a perfect mandibular fit.
Inclusion: 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:; oCT angiography of the legs and/or the neck shows severe stenosis of the ves-sels; Previous medical history of severe atherosclerotic disease; 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: 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; Patients who are eligible for free fibula flap; Pregnancy.