Clinical trial · Interventional
Improved Implant for Reconstruction Purposes After Mandibular Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): End point is reached with 1 implant which is removed within the observation period
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RIFRAM implant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RIFRAM implant
- description
- RIFRAM implant
- interventionNames
- Device: RIFRAM implant
Primary outcomes (2)
- measure
- Surgical fit
- timeFrame
- intra-operative
- description
- good fit during surgery, suboptimal fit of the mandible making placement not possible.
- measure
- Complications
- timeFrame
- implant loss in 1-year post-operational follow-up.
- description
- Implant related complications leading to implant loss
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available