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.

NCT ID: NCT04773847

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-10-31

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).

Conditions

Bone Regeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MimetikOss 3D

Group Type: EXPERIMENTAL

Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

Intervention Type: PROCEDURE

Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

Interventions

Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mimetis Biomaterials S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Òscar Escuder i de la Torre

Role: PRINCIPAL_INVESTIGATOR

University Hospital Parc Taulí Sabadell

Central Contacts

Emilie Thorel

Role: CONTACT

Phone: +33672121897

Email: emilie.thorel@mimetis.es

Emilie Thorel

Role: CONTACT

Email: cr@mimetis.es

Other Identifiers

2020/743

Identifier Type: -

Identifier Source: org_study_id