Patient-specific maxillofacial reconstruction implants

Description

Epidemiological data shows that maxillofacial defects are most common among young people of working age. The most common defects of this area are fractures that are caused by high energy trauma (accidents, sport injuries, industrial injuries, etc.). Not so common defects include deformities and defects caused by various illnesses. Deformation of facial skeletal bones distorts the patient’s facial proportions and may compromise the stomatognathic system, visual and olfactory systems, the function of the lower jaw.

In clinical practice for maxillofacial reconstruction, bone grafts, bone cement and standard implants (meshes, plates and screws, augments) used are traditionally shaped manually (bent and cut), either preoperatively or intraoperatively. However, with these materials, it is difficult to restore the aesthetic of the face and evenly fill the defects, which may lead to irregular healing of the bone and unsatisfying aesthetic results. Patient-specific maxillofacial reconstructive implants solve these problems. Therefore, in case of large maxillofacial defects and in order to restore the patient’s aesthetic and decrease the risk of infections and other complications, it is recommended to use patient-specific maxillofacial reconstruction implants that are manufactured individually for each patient with regard to the patient’s anatomy, pathology and the requirements for the design of the implant defined by the surgeon.

Manufacturing patient-specific maxillofacial reconstruction implants includes conventional bone cement (PMMA) and silicone materials as well as the following materials: titanium, titanium alloys (Ti6Al4V, Ti6Al4V-ELI), polymeric materials (PHDPE, PEEK and PEKK) and bioceramics. 3D printing gives implants added value because it has almost no limitations in the realization of the most complex geometries and enables forming trabecular metal surfaces that ensure better secondary fixation of the implant.

Material	Advantages	Disadvantages
Titanium and titanium alloys	Great osteointegration Can be made with lattice structure Great strength properties Mechanically stable 3D printed	Radiopaque Stiff Cost+
Polymers: PEEK (polyether-ether-ketone), PEKK (polyether-ketone-ketone)	Radiolucent Elasticity Bone like properties Light weight 3D printed	No interaction with bone Only small sample clinical studies Cost++
Bioceramics	Bone like structure Radiolucency Great osteointegration Can be 3D printed	Cost +++ Only small sample clinical studies Shatter
Material Combination	Various properties may be obtained depending on the surgeon’s requirements and individual patient’s case	No clinical studies or small sample clinical studies

The designs for patient-specific maxillofacial reconstruction implants are only limited by the surgeon’s imagination and the patient’s aesthetic needs.

Patient-specific maxillofacial reconstruction implants are manufactured individually for each patient with regard to the patient’s anatomy, pathology and the requirements of the treating surgeon for the design, fixation solutions and materials used. They are designed on a personalized maxillofacial anatomical model that is recreated from computer tomography scan images. Therefore, a patient-specific implant suits the patient’s anatomy perfectly and evenly fills the defects thus aesthetically restoring the maxillofacial morphology and symmetry, and occlusion (if applicable), and using patient-specific surgical guides ensures accuracy of implant positioning and insertion. If requested, maxillofacial reconstruction implants can be designed to be used for flap reconstruction surgeries (e.g. mandibular reconstruction using fibula / iliac flap).

Manufacturing and materials for patient-specific maxillofacial reconstruction implants GIFIT

All the materials, software and hardware used to manufacture patient-specific maxillofacial reconstruction implants and surgical guides are certified:

Ortho Baltic patient-specific maxillofacial reconstruction implants GIFIT are manufactured using additive manufacturing technology DMLS from medical grade titanium alloy Ti6Al4V;
Single-use patient-specific surgical guides, patient-specific anatomical and implant models used in presurgical planning as well as for planning and training purposes during surgeries are printed from biocompatible polymer (PA 2200, also known as Nylon-12), using additive manufacturing technology SLS.

Detailed information about patient-specific implant design, manufacture and validation process are available here.

If you prefer to use a different material than Ti6Al4V, please contact us.

Composition of Ortho Baltic patient-specific maxillofacial reconstruction implant package

Implant components of Ortho Baltic patient-specific maxillofacial reconstruction implant package include the following:

Patient-specific maxillofacial reconstruction implant(-s);
Patient-specific maxillofacial reconstruction implant trial(-s) (optional);
Patient-specific surgical guides (optional);
Patient-specific anatomical and implant models (virtual or materialized) that are intended to be used for presurgical planning;
Standard implant fixation screws (optional);
Documentation (implant passport, instructions for use, etc.).

If you would like to order a patient-specific implant, have any questions or any specific requirements concerning the patient-specific implant package, please fill out the form below.