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3DP Modularized Finger PIPJ Arthroplasty
           into the natural articular surface using the iterative closest   and greater than the joint surface over two levels were
           points (ICP) algorithm provided in the Mimics software.   excluded, leaving the modularized PIP joint implant the
           The calculation formula is shown in :               modularized  with the same size and the joint surface
                                         [9]
                  (
                E R,  ) T   = ∑ n = i  1  ( ( * +R pi T ) − qi )2  greater than one level of the stem. From the anatomical
                                                               and clinical consideration, the medullary cavity could be
               where  pi  is the  point  cloud  coordinates  for  the   occasional smaller due to thick metaphyseal of diaphyseal
           alignment  model P, qi is the point cloud coordinates   cortical bone. However, mismatch with large medullary
           for the target alignment  model Q,  n is the number   cavity with smaller articulation was seldom observed,
           of reference point clouds (n = 1000), R is the rotation   which may affect the range of motion of joint. Under such
           matrix, and T is the translation matrix. Each iteration is   conditions there were a total of nine sets of specifications
           intended to calculate the distance between the point cloud   (Table 1).
           pi coordinates for the alignment model and the point    For  the  subsequent  functional  biomechanical
           cloud qi coordinates for the target alignment model after   test  requirements,  it  was necessary to  determine  the
           matrix transformation. The iteration was stopped when   combination  of  nine  PIP  joint  implant  specification
           the difference between the front and rear transformation   sets with the  weakest  structure after  the  PIP joint  was
           matrices is less than the set threshold value. This iteration   implanted with the phalanx. When the medullary cavity
           process enabled phalanges of different sizes to align with   ratio  to the  entire  phalanx  cross-sectional  areas  was
           the large shared volume. Natural articular surfaces in the   largest, that  is, the one with the smallest  cortex  bone
           clinical representatives were obtained by averaging the   thickness  was  defined  as  the  weakest  state  structure.
           coordinates from the 48 aligned point clouds of phalanx   A  structural weakness combination  from the nine PIP
           articular surfaces (Figure 2A).                     joint implants can be found using the following three
                                                               steps: (i) the phalanges with the largest size, medium
           2.2. Modularized PIP joint implant system           size (averaged size) and the smallest size among the 48
           design and worst structure case definition          phalanges were screened; (ii) corresponding medullary
           The components for resurfacing the PIP joint implant   cavity ratio to the cross-sectional area at the phalanx stem
           include  three  parts, bi-condylar surface  with elliptical-  top and bottom sides of the previous largest and medium
           cone stem of proximal phalanx, the bi-concave articular   sizes  were  obtained  and  these  sizes  were  recorded  to
           surface of middle phalanx, and the elliptical-cone stem   find the phalange with maximum ratio, that is, the PIP
           of middle phalanx. The bi-concave articular surface was   joint with the thinnest cortex bone case; and (iii) the
           designed to connect with the elliptical-cone stem using a   combination of nine groups of PIP joint implants that can
                                                               be put into the case of the thinnest cortex bone with the
           hook mechanism (Figure 2B and C).                   largest stem size was checked. Furthermore, a larger force
               The averaged stem lengths (12  mm for proximal
           stem and 7.5 mm for middle stem), major and minor axis   state can be generated when the articular surface level was
                                                               larger than the corresponding stem level combination.
           of the elliptical-cone stem at metaphyseal and diaphyseal
           for proximal and middle phalanxes were calculated from   Therefore,  the structural  weakness combination  from
           the 48 sets of phalanx CT image data and noted as the   the nine PIP joint implants can be found and defined as
           standard  size  specification  (Figure  2B and  C). Since   the worst structure case. This combination was used for
           the size of 20% above/below the standard PIP joint   functional mechanical test to observe the biomechanical
           implant size was about the average dimension plus/minus   performance  of  modularized  pairing  under  different
           1.3 standard deviation, covering about 80% of the 48   specifications.
           phalanges’ size. The size was set at 20% above and below   2.3. 3D printing manufacture of the worst PIP
           the averaged standard size as the maximum and minimum   joint implant
           sizes, respectively.  An intermediate  size of 10% was
           inserted  to cover the entire  PIP joint  implant  detailed   The proximal phalangeal stem and articular surface
           size range. Finally, a total of five sizes for the PIP joint   components as well as the middle phalangeal stem were
           implant,  consisting  of  20%,  10%,  standard  size,  −10%   fabricated by metal 3D printer (AM400, Renishaw,
           and −20%, were considered (Table 1). There were five   Gloucestershire, UK) with titanium alloy powder (about
           specifications for both the articular surfaces and the cone   30 μm), which had been proved with good biocompatibility
           stems for proximal and middle phalanxes, which in free   and was also used widely in clinical practice. Our 3D
           combination  would make up 25 sets of modularized   printer laboratory was approved by ISO13485 quality
           specifications.                                     management system (Certificate Number: 1760.190828)
               Considering  the  more  plausible  combination  of   to ensure that implants manufactured by 3D printing can
           the stem and articular surface of anatomical proportion,   provide a practical foundation to meet the regulations,
           the modularized PIP joint implant with the stem smaller   such as printing material with biocompatibility in the

           154                         International Journal of Bioprinting (2022)–Volume 8, Issue 3
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