Introduction
The design and manufacturing of the customized implants Unique® are based on computer tomography (CT) scans. The CT data are used to create a three-dimensional reconstruction of the femoral canal. Several design criteria have been established and are implemented in the computer aided design (CAD) and the computer aided manufacturing (CAM) of the implant.


The process of producing a customized implant


Computer Tomography (CT) scanning of the patient
Along with the purchase order for a SCP Unique custom femoral implant, the orthopaedic surgeon refers the patient to a CT scanning of the involved hip. During the CT scanning, 30 transverse images are obtained from the hip joint and the upper femur. The CT scanning takes about 15 minutes and is completely painless.


A CT scanner (left), scout view of a left hip with position levels of CT images (middle) and a transverse CT image of intertrochanteric region of the femur (right).


Analysing the CT images and designing the implant
The CT images are analyzed using special software developed by SCP. It generates contours to describe the implant design. The combination of all these contours forms the basis for the three-dimensional computer model of the implant.


CT images in SCP software with implant contours (left). A complete 3D computer model of the designed implant (right).


Manufacturing the implant
The 3D computer model of the implant forms the basis for the manufacturing of the implant. The implant is processed in a 5-axis machining centre. The implant is manufactured in titanium alloy (Ti6Al4V ELI) according to the ASTM standard for using this alloy in implants (ASTM F136-92).
An individual implant requires an individual rasp for broaching the medullar canal of the femur. This rasp has to have the same geometry as the implant to provide the right seat for the implant. The rasp is processed in approved steel and provided with sharp teeth for effective broaching.



A view from the CAM (Computer Aided Manufacturing) software(left) and milling in the machining centre (right).


Finishing treatment
The implant is coated with hydroxyappatite (HA) in the area of contact stabilizing bone. It is then cleaned, packed and sterilized using gamma irradiation. The broaches are glass blasted, cleaned and checked before being sent to the hospital.


Implant with HA-coating and its corresponding broach.