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.

NCT04773847 | Unknown

• 1 other identifier: 2020/743
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Geometric evolution of the grafted volume through radiological evaluation

  6 months post-surgery

Secondary Outcomes (9)

• Geometric evolution of the grafted volume through radiological evaluation

  12 months post-surgery

• Versatility of MimetikOss 3D patient-specific bone substitute

  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

Study Arms (1)

MimetikOss 3D

EXPERIMENTAL

Procedure: Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

Interventions

Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D. PROCEDURE

Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.

MimetikOss 3D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mimetis Biomaterials S.L.: lead

Study Officials

• Òscar Escuder i de la Torre

  University Hospital Parc Taulí Sabadell

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Thorel

CONTACT

+33672121897; emilie.thorel@mimetis.es

Emilie Thorel

CONTACT

cr@mimetis.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Since the studied medical device is a custom-made product, only one group is considered.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR