Clinical trial NCT04773847: The Clinical and Radiographic Outcomes of a 3D-printed Patient-specific Biomimetic Bone Substitute in Maxillofacial Indications: an Interventional, Multi-centred, Open-label, Post-market Clinical Investigation.
Official title: The Clinical and Radiographic Outcomes of a 3D-printed Patient-specific Biomimetic Bone Substitute in Maxillofacial Indications: an Interventional, Multi-centred, Open-label, Post-market Clinical Investigation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Regeneration
Lead sponsor: Mimetis Biomaterials S.L.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Since the studied medical device is a custom-made product, only one group is considered.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Male or female age 18 years or over at the time of inclusion into the study;
* Ability to obtain written informed consent from the recipient;
* Patients in need of craniomaxillofacial bone regeneration;
* Ability and capacity to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient;
* Patients with good general hygiene;
* Radiographic exam allowing a complete observation of the osseous defect;
* Mimetis approval of the feasibility.

Exclusion Criteria:

* Active tumour;
* Passive tumour with cancer recurrence within 10 years;
* Practice of intensive contact sport exercise during the clinical trial duration;
* Concomitant participation in other clinical trials;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
* Women who are breastfeeding;
* Alcohol or drug abuse as noted in subject records or in subject history;
* Patients with a medical condition that may compromise the healing process or history of systemic diseases that would contraindicate the surgical treatment or any other disease that might have an influence on the involved tissues, such as: severe metabolic disorders, osteogenesis imperfecta, osteoporosis, infectious and degenerative bone diseases, immunodeficiency (congenital or acquired), autoimmune disease, Osler-Weber-Rendu syndrome, unbalanced diabetes, transient hypercalcemia, allergic disposition to phosphate calcium components, titanium or collagen etc; immunosuppressive therapy, steroid therapy, heparin treatment, corticoid treatment, treatments that interfere in the calcium-phosphate metabolism, bisphosphonate intake, Paclitaxel treatment, methotrexate medication etc);
* Acute and chronic infections in the surgery area (e.g. soft tissue infections, inflammatory and bacterial osteopathy, osteomyelitis) and / or mucosal diseases in the areas to be treated;
* In case of intraoral surgery, heavy smokers (\>10 cigarettes) excluded;
* Inability to return for follow up visits.

Primary outcomes:
measure: Geometric evolution of the grafted volume through radiological evaluation
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Geometric evolution of the grafted volume through radiological evaluation
timeFrame: 12 months post-surgery
measure: Versatility of MimetikOss 3D patient-specific bone substitute
timeFrame: 12 months post-surgery
measure: Incidence of serious adverse events and adverse events
timeFrame: during the surgery / 6 months post-surgery / 12 months post-surgery
measure: Bone union observation
timeFrame: 12 months post-surgery
measure: Surgical technique improvement in terms of accuracy of MimetikOss 3D design and positioning
timeFrame: directly after the surgery / 6 months post-surgery / 12 months post-surgery
measure: Surgical technique improvement in terms of total surgery duration and duration of implantation of MimetikOss 3D
timeFrame: during the surgery
measure: Surgical technique improvement in terms of blood loss measurement
timeFrame: during the surgery
measure: Surgical technique improvement in terms of surgeon satisfaction
timeFrame: 12 months post-surgery
measure: Aesthetic evaluation by visual observation of the symmetry of the face, pictures and/or irregular contours prosthetic palpable (if applicable)
timeFrame: directly after the surgery / 6 months post-surgery / 12 months post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Parc Taulí Sabadell
name: Òscar Escuder i de la Torre
role: PRINCIPAL_INVESTIGATOR
References: