Improved Implant for Reconstruction Purposes After Mandibular Resection (NCT05153733) | Clinical Trial Compass
TerminatedNot Applicable
Improved Implant for Reconstruction Purposes After Mandibular Resection
Stopped: End point is reached with 1 implant which is removed within the observation period
Netherlands3 participantsStarted 2021-11-29
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical fit
Timeframe: intra-operative
2
Complications
Timeframe: implant loss in 1-year post-operational follow-up.