GENERAL

Is there a CBCT scanning protocol available?
Yes, use the Scan protocol that can be downloaded in the Downloads section.
Please be aware that CBCT scanners are accepted for TRUMATCH CMF Titanium 3D Printed Plates, Guides and Orbital Implants. Due to potential distortion, CBCT data is not accepted for the Titanium 3D Printed Implants (porous implants). 

How are the patient specific devices manufactured?
Titanium patient specific devices are manufactured by Selected Laser Melting (SLM) of Commercially Pure Grade 2 Titanium Powder (CPG2Ti), layer by layer, using a high-power laser.
 
How are the patient specific devices packaged?
Materialise patient specific devices are packaged non-sterile, single use. 

How are the Titanium 3D printed plates, guides and implants devices fixated?
Titanium 3D printed plates, guides and implants can be used with the applicable Matrix screw system
(MatrixORTHOGNATHIC, MatrixMIDFACE, MatrixMANDIBLE or MatrixNEURO). 

Can I work with a Clinical Engineer to plan the case?
Yes, Clinical Engineers are trained to plan all TRUMATCH CMF cases (with or without 3D printed plates and implants).

I prefer to plan my own cases using software like ProPlan CMF. Does Materialise accept cases planned by the surgeon?
Yes. Materialise requires the DICOM data and, if relevant, dental occlusion data for quality checks during the design process.

For the use of STL files, please address an enquiry via the Contact section.

TRUMATCH CMF TITANIUM 3D PRINTED PLATES AND GUIDES

What is it?
This is a direct and fully guided system for bone part repositioning.
The Titanium 3D Printed Plates and Guides system consists of patient specific osteotomy and drill guides and patient specific plates for the transfer of the surgical plan to the operating room.

How does it work?
Patient specific devices are designed based on the virtual surgical plan using the patient’s CT data and (if relevant) the patient’s dental occlusion data, using specialized software.

How is the dental data obtained?
It is the same as a regular TRUMATCH orthognathic case. The patient’s dental occlusion data can be obtained through scanning of the physical dental impressions locally or at Materialise, or alternatively from an intra-oral scanner. Data or physical models can be sent to Materialise or uploaded directly to the case. The final desired occlusion is determined by the surgeon and can be set virtually (generally not preferred method of surgeons due to no tactile feedback) or through the use of a registration bite or minimum of three registration lines on the dental plaster molds.

For the Titanium 3D Printed Orthognathic LeFort 1 plate, is it possible to have the plate in two parts (i.e. not linked in the center)?
Yes.

Is it possible to incorporate additional screw locations in the plate to provide more fixation options?
While the standard number of screws at each fixation point on either side of the osteotomy is 2, a third screw can normally be accommodated on request. Either in linear or clover distribution.

Is it possible to design the LeFort 1 osteotomy guide in a closed design, rather than with a gap?
Yes, a closed guide can be incorporated in the design on request.

What is the plate profile?
The standard plate profile for orthognathic patient specific plates is 1.0mm. On request and for secondary osteotomy and repositioning of the zygoma, a plate profile of 0.8mm is also available.

Can 3D Printed devices for Orthognathic surgery be used for surgery with a segmented maxilla or mandible?
Yes, the devices are also designed for cases with segmented mandibles and maxillas. Designs can incorporate 2 or 3 segments for the maxilla. Some surgeons also like to use splints for additional stability in these cases. The plate design is modified to provide additional stability.

Can the plates incorporate a mesh for graft containment?
Yes.

Do the orthognathic guides require more exposure than would normally be required?
Yes. Typically, an additional ½ cm of exposure is required on each side for the placement of the Titanium 3D Printed guide, relative to regular surgery without guides.
 
 
TRUMATCH CMF TITANIUM 3D PRINTED IMPLANTS

What is a TRUMATCH CMF Titanium 3D Printed Implant?
This is a complete and comprehensive solution for patient specific implants.
 
The specific porous structure used for TRUMATCH CMF Titanium 3D Printed Implants has been designed to mimic the orthotropic properties of bone and to promote osseointegration (Barbas, A, et al., Development and Mechanical Characterization of Porous Titanium Bone Substitutes, (2012), DOI:10.1016/j.jmbbm.2012.01.008).
 
Is TRUMATCH CMF Titanium 3D Printed Implant MRI Conditional?
Yes. As stated in the IFU:
 
PRECISION ON MRI OR CT SCAN: MR CONDITIONAL Non-clinical testing and MRI simulations performed on the TRUMATCH CMF Titanium 3D Printed Implants demonstrated that a patient with one of these implants can be scanned safely in an MR system immediately after placement under the following conditions:
Static magnetic field of 1.5 Tesla or 3 Tesla, only.
Maximum spatial field gradient magnetic field of 2,000 gauss/cm (20 T/m) (extrapolated value)
Maximum MR System reported, whole body averaged specific absorption rate
(SAR) of 2 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode of operation for the MR system.
Under the scan conditions defined above, an implant from the TRUMATCH CMF Titanium 3D Printed Implants is expected to produce a maximum temperature rise of less than or equal to 2.9ºC after 15 minutes of continuous scanning (i.e., per pulse sequence).
 
In non-clinical testing, image artifacts caused by an implant from the Titanium 3D Printed Implants family extend approximately 10 mm from the device when imaged using a gradient echo pulse sequence and a 3 Tesla MR system. 

What is the porosity of TRUMATCH CMF Titanium 3D Printed Implants?
53%.