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Wang, et al.
           stability of bone under different fixation conditions [4,5] .   2. Materials and methods
           Structure properties of composite Sawbones such as
           mineral density and elastic modulus approach to the   2.1. Study design
           human bone ensure compliance with the requirements   Fourteen  fourth-generation  composite   femurs
           of bone mechanical testing [6-8] . Therefore,  composite   (Model  3406;  Pacific  Research  Laboratories,  Vashon,
           Sawbones and human cadavers have often been used    Washington, USA) were used to simulate osteotomy.
           in mechanical trials. Establishment of bone traumatic   Bone materials properties and geometrical parameters
           models  according  to  standard  fracture  classifications   were close to fresh-frozen cadaveric femurs  (Table  1
           requires precise and shape-matching osteotomy.      and  Figure  1) [6,17-20] .  Computed  tomography  (CT)
           However, the osteotomy methods vary among different   scans of one composite Sawbone was performed on
           research groups [5,8-11] , restricting the homogenization,   a 64-slice CT scanner (Siemens Sensation Open,
           and universality of different mechanical study to some   Erlangen, Germany). Scan slice thickness was 5  mm.
           extent.                                             Digital Imaging and Communications in Medicine files
               To date,  few bone  biomechanical  studies  used   (DICOM) of the selected CT scans were retrieved and
           the osteotomy-aided  modules for precise creation of   loaded in Mimics software (Version 20.0, Materialise,
           fracture sample. Windolf et al.  firstly introduced their   Belgium).  The femur and medullary cavity models
                                     [9]
           osteotomy-aided  modules named custom-made  saw-    were then reconstructed in Mimics. Subsequently, the
           guide for unstable 31-B2 fracture models and realized the   above 3D reconstructions were imported into 3-Matic
           smooth osteotomy. Rupprecht et al. subsequently utilized   (Version  12.0,  Materialise,  Belgium)  in  STL  formats
           this device for biomechanical analysis . In addition,   to design osteotomy models.  The osteotomy models
                                             [12]
           another  osteotomy  module  featuring  cutting  navigation   were, then, obtained and imported into 3D printer
           was proposed by Windell et al.  in a biomechanical study   (OBJET  EDEN260V,  Stratasys  Ltd,  Rehovot,  Israel)
                                    [8]
           comparing  different  implants  in  periprosthetic  femoral   to manufacture anatomical osteotomy modules for
           fracture.  Unfortunately, the  study did not evaluate  the   intertrochanteric fracture. Finally, after assembling
           accuracy  of  osteotomy.  Challenges  such as  time-  and   the composite Sawbones and osteotomy modules,
           manpower-consuming aspects and high cost in industrial   osteotomy was performed using horizontal band-saw.
           designs and application also limit the experimental use of   The study flowchart is shown in Figure 2.
           these device.
               Computer-aided  design (CAD) technique  can     2.2. Computer-aided design (CAD)
           precisely establish the three-dimensional (3D) digital bone   2.2.1. Osteotomy models
           models, extract local parameters at the site of interest, and
           design precise osteotomy-aided modules with the help of   We used  AO/OTA 31  A2.3 intertrochanteric  unstable
           engineering software . 3D printing technique has been   fracture  model  design as an example. The central  axis
                            [13]
           recently applied to the domains of regenerative medicine   of femoral shaft was established in 3-Matic, and a plane
           of tissues and organs, surgical decisions-making,   perpendicular to the placing plane was obtained through
                                                                            [13]
           personal design of tissue engineering scaffolds materials,   the central axis . The plane was rotated 20° clockwise
           and prosthetic or implants in orthopedic . Compared   with Y-plane as the rotation center, and a set of parallel
                                              [14]
           with traditional industrial design, 3D printing technique   osteotomy reference planes could be established based on
           reduces labor and material costs, simplifies workflows,   the obtained plane. The horizontal plane (parallel to the
           and improves consistency. The advantages of 3D printing   XY plane) was established based on the tip of the greater
           applied to medical devices design are numerous, such as
           high production efficiency, high level of design precision,
           fine anatomical fitting, and good repeatability [15,16] .
               Based on above, we believe that the combination
           of CAD and 3D printing techniques can help establish
           precise osteotomy-aided modules matching bone
           morphology  and  confirm  homogenization.  Further
           studies are warranted. Therefore, considering the design
           of AO/OTA 31 A2.3 intertrochanteric unstable fracture
           models as an example, the present study aims to design
           a new method of osteotomy-aided module production
           for bone biomechanical study with the help of 3D
           printing coupled with CAD and to test the accuracy of
           osteotomy.                                          Figure 1. Geometrical parameters of Sawbones.

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