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The purpose of the study is to evaluate the clinical and radiographic outcome of MimetikOss 3D as a patient-specific bone substitute in regeneration of osseous defects in several maxillofacial indications. The primary objective is to evaluate the capacity of MimetikOss 3D to perform bone substitute requirements, i.e long-term regeneration of bony tissue in complex defects without detrimental resorption. The secondary main objectives are to assess the versatility of MimetikOss 3D by the variety of maxillofacial sites regenerated and the surgical technique improvement (in terms of surgery duration, blood loss, ease-of-use of the product and surgeon satisfaction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MimetikOss 3D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. | Procedure | Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric evolution of the grafted volume through radiological evaluation | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric evolution of the grafted volume through radiological evaluation | 12 months post-surgery | |
| Versatility of MimetikOss 3D patient-specific bone substitute | MimetikOss 3D can be implanted to regenerate osseous defect from different indications of the maxillofacial area (dental area, jaw and maxilla reconstruction, zygomatic reconstruction and/or chin reconstruction for instance). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Thorel | Contact | +33672121897 | emilie.thorel@mimetis.es | |
| Emilie Thorel | Contact | cr@mimetis.es |
| Name | Affiliation | Role |
|---|---|---|
| Òscar Escuder i de la Torre | University Hospital Parc Taulà Sabadell | Principal Investigator |
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Since the studied medical device is a custom-made product, only one group is considered.
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| 12 months post-surgery |
| Incidence of serious adverse events and adverse events | during the surgery / 6 months post-surgery / 12 months post-surgery |
| Bone union observation | 12 months post-surgery |
| Surgical technique improvement in terms of accuracy of MimetikOss 3D design and positioning | directly after the surgery / 6 months post-surgery / 12 months post-surgery |
| Surgical technique improvement in terms of total surgery duration and duration of implantation of MimetikOss 3D | during the surgery |
| Surgical technique improvement in terms of blood loss measurement | during the surgery |
| Surgical technique improvement in terms of surgeon satisfaction | 12 months post-surgery |
| Aesthetic evaluation by visual observation of the symmetry of the face, pictures and/or irregular contours prosthetic palpable (if applicable) | directly after the surgery / 6 months post-surgery / 12 months post-surgery |