Concept Design and Possibility Study Interpedicular

Locking Screw Implant Fixation for Osteoporosis Bone

Radhi Maladzi1,a), Sugeng Supriadi2, b), and Yudan Whulanza2,c
1
Department of Mechanical Engineering, Faculty of Engineering, Universitas Indonesia.
2
Research Center for Biomedical Engineering, Universitas Indonesia
a)
radhi.maladzi@ui.ac.id
b)
sugeng@eng.ui.ac.id
c)
Corresponding author: yudan@eng.ui.ac.id

Abstract. Osteoporosis is a condition which bone become fragile. Osteoporosis vertebrae bone causes fracture easily
and also decreases fixation strength between pedicle screw implant and spine bone. Lack of fixation strength between
pedicle screw implant and osteoporotic vertebrae bone lead to implant failure such as pedicle screw pull out. Therefor
the purpose of this research is to develop intrapedicular locking screw concept of pedicle screw implant system which
can resist pull out failure on osteoporotic bones. The main objective of this study is to know the possibility of
intrapedicular locking screw for vertebral segments. The method of this study is by simulate the position of
intrapedicular locking screw design for each vertebral segment using solidworks. Vertebral segments CT Scan sample
is taken from one of the patient. After each pedicle screw is positioned correctly the vertebral segments, pedicle screw
position angel is measured. The result from measuring the position angle from pedicle screw it obtain the angle
between 40°-70° for each vertebral segments sample. After this study is done, it concludes if the intrapedicular concept
can be applied almost every vertebral segments.

Keywords: Fixation; Implant; Lumbar; Osteoporosis; Pedicle screw; Pull Out;

INTRODUCTION
Osteoporosis is a condition where whole bones become fragile so it decrease bone’s strength and lead to bone
fracture easily, it happened because of aging so that makes bone mineral density become low (marcus et al.,2009).
Osteoporosis is one of the cause of backbone fracture, the most necessary vertebral segment is lumbar because it
supports body movement at most [1-2].

Medical treatment to overcome vertebral bone fracture need some instrumentations to maintain the vertebral bone,
one of the instrumentation to fixate the bone is using pedicle screw. Pedicle screw fixation instrumentation system for
vertebral bone is firstly introduced by Harrington and tulos at 1969, until nowadays it becomes the main
instrumentation for spinal surgery [3].

However, pedicle screw ability to maintain on osteoporotic bones condition become questionable because it makes
the vertebral bones become fragile and weaken the bond between pedicle screw and the bones. Decreased excessive
fixation strength on pedicle screw can cause loosening and pull out failure easily [4-6].

Various studies have been conducted to increase fixation strength of pedicle screw on osteoporotic bones, one of
the study is modifying the geometry to increasing pull out force on pedicle screw [7]. Although the geometry of pedicle
screw has been modified but pull out failure still can happen on severe osteoporosis condition. Other technique to
strengthen fixation bond between pedicle screw and the bone is using bone cement. On stadelman et al research,
explained using biocompatibility material such as calcium phosphate (CaP) as bone cement then injected to the
vertebral bone by cannulated pedicle screw to prevent pull out failure [8]. Even though bone cement able to increase
a lot pull out force on pedicle screw, bone cement utilization still has some deficiencies such as leakage that leads to
spine tissue injury [8-9].

Therefor a new concept has to be developed such as both of pedicle screw connected each other with a new system,
it means both of them will mutually reinforcing each other and increase the pull out force on osteoporosis bone without
using bone cement.

METHODS

Pedicle Screw Modeling

Reverse engineering process is to obtain geometric CAD model from physical or existing product. Reverse
engineering concept is used to design pedicle screw from existing product. Firstly, commercial pedicle screw is
measured with digital microscope dinolite to get the dimension of it can be seen on figure 1. Benefit using dinolite is
could see and measure small detail geometry of pedicle screw. Pedicle screw consist of 3 different geometries which
are head, body and tip. Each geometry using various magnification scale which is adjusted to accuracy of the dinolite.

FIGURE 1. Using Digital Microscope on Comercial Pedicle Screw

After that, pedicle screw is designed with solidworks to get the CAD model of pedicle screw from existing product
that can be seen on figure 2. Every dimension in pedicle screw CAD model is based on measuring with digital
microscope dinolite.

FIGURE 2. 3D Model Pedicle Screw

 Concept Design Interpedicular Locking Screw
The purpose of development concept pedicle screw is to prevent pedicle screw undergo pull out failure from
osteoporosis bone condition. A design concept of interpedicular locking screw which is both of pedicle screw binding
each other through the wire and improve fixation strength of both pedicle screws itself, Because the common
commercial pedicle screw doesn’t bind each other. From this concept the pedicle screw has a hole through the whole
body and each of pedicle screws should be connected as a medium which can be passed by the wire, the design concept
can be seen on figure 3.

FIGURE 3. 3D Model Concept Design Interpedicular Locking Screw

This initial concept of interpedicular locking screw should be tested by various study, one of the study is possibility
concept design implementation on vertebral bone is done in this reasearch.

Segmentation Process Vertebrae Bone

In this segmentation process, CT scan data with dicom format is obtained from one of the patient as can be seen
on figure 4. 3d slicer is a software for image processing from CT Scan data which in dicom format. After that using
3d slicer software to do the slicing process. Slicing process in 3d slicer is a process to get a segment which is desired
from total segment from CT scan data. The purpose of this process is to be more focus on manipulate the vertebral
bone which is desired.

FIGURE 4. CT-Scan Dicom Data from a Patient

There are 33 total vertebrae bone segments on human body however because of the vertebrae bone in bad condition
and many damaged bones so there are 12 vertebrae bones that possibly to be sliced using 3d slicer software. Total
vertebrae bone segments that success to be sliced are lumbar segment (L4, L5,); thoracic segment (T1, T2, T3, T4,
T5, and T7); and cervical segment (C5, C6, and C7) those vertebral bone segments will be studied with pedicle screw
3D Model. Finaly, vertebral bone segments will be transferred to solidwork software using IGES format.

Design Possibility Study

This virtual surgery concept study using solidwork software for manipulating pedicle screw position to the
vertebrae segment. In this process, the 3D model pedicle screw position is moved and adjusted to every vertebrae bone
segment. Pedicle screw entrance and path in vertebrae bone segment follow the vertebrae bone surgery process.
Another requirement appropriate to the design concept is both of pedicle screw tip should be meet in 1 point as can
be seen in figure 5.

FIGURE 5. Pedicle Screw Placement Simulation Using Solidwork

After both of pedicle screw meet each other, angle each pedicle screw for every various size bone segment will
be measured and evaluated.

RESULTS AND DISCUSSION

After some process have been done, the possibility design study in vertebrae segments obtain some result. Pedicle
screw placement simulation in vertebrae bone almost every vertebrae segment except on cervical segment (C5). The
other vertebrae bone segment shows both of pedicle screw can meet at one point so it means it is applicable with the
design concept intrapedicular locking screw.

TABLE 1. Pedicle Screw Angle on Vertebra Bone Segment

Vertebrae Bone Segment Pedicle screw 1 angle Pedicle screw 2 angle
Lumbar L5 40.97° 43.01°
Lumbar L4 52.04° 67.57°
Thoracic T7 56.26° 67.02°
Thoracic T6 60.14° 68.64°
Thoracic T5 61.31° 61.14°
Thoracic T4 56.80° 68.38°
Thoracic T3 61.16° 67.43°
Thoracic T2 56.71° 59.00°
Thoracic T1 49.50° 55.90°
Cervical C7 50.61° 54.41°
Cervical C6 48.10° 55.42°
Cervical C5 Not possible Not possible
 the angle is formed within both pedicle screw can be seen on table 1 It can be seen the angle which is formed is
between 40°-70°. However, the result angle is uncommon and various kinds then It is important to provide an
instrument for pedicle screw so pedicle screw entry direction could be determined. Other things, that pedicle screw
size is too big for some of the vertebrae bone segment so it can injure or harm spine nerves.

CONCLUSION
Based in this study, design concept intrapedicular locking screw can be applied almost every obtained vertebrae
bone segment because both of pedicle screw could meet in one point except on cervical segment (C4).
Pedicle screw variations need to be done because of varied size vertebrae bone segment since in some vertebrae
segment pedicle screw almost touch spine nerve.
To implemented this concept, in actual surgery need some instrument tools for establish pedicle screw path and
angle, because as can be seen on figure. the angle is provided is uncommon between 40°-70°.
In this intial study from design concept of interpedicular pedicle screw need other test or study to realize and
manufacture the product.

ACKNOWLEDGMENT
The authors would like thank to the Direktorat Riset dan Pengabdian Masyarakat (DRPM) Universitas Indonesia
for funding this research.
 REFERENCES
1. Marcus, Robert, et al. (ed.). Fundamentals of osteoporosis. Academic Press, 2009.
2. Gray, Linda; Vandermark, Robert; Hays, Matthew. Thoracic and lumbar spine trauma. In: Seminars in
Ultrasound, CT and MRI. Elsevier, 2001. p. 125-134.
3. Faciszewski, T.; Mckiernan, F. E.; RAO, R. Management of osteoporotic vertebral compression fractures.
Orthopaedic Knowledge Update-Spine, 2006, 3.
4. Amirouche, Farid; Solitro, Giovanni F.; Magnan, Brenden P. Stability and Spine Pedicle Screws Fixation
Strength—A Comparative Study of Bone Density and Insertion Angle. Spine deformity, 2016, 4.4: 261-267.
5. Lai, Dar-Ming, et al. Effect of pedicle screw diameter on screw fixation efficacy in human osteoporotic
thoracic vertebrae. Journal of biomechanics, 2018, 70: 196-203.
6. Mehta, H., et al. Biomechanical analysis of pedicle screw thread differential design in an osteoporotic cadaver
model. Clinical Biomechanics, 2012, 27.3: 234-240.
7. Shea, Thomas M., et al. Designs and techniques that improve the pullout strength of pedicle screws in
osteoporotic vertebrae: current status. BioMed research international, 2014, 2014.
8. Gao, Mingxuan, et al. Biomechanical evaluation of fixation strength of conventional and expansive
pedicle screws with or without calcium based cement augmentation. Clinical Biomechanics, 2011,
26.3: 238-244.
9. Stadelmann, Vincent A., et al. Calcium phosphate cement augmentation of cancellous bone screws can
compensate for the absence of cortical fixation. Journal of biomechanics, 2010, 43.15: 2869-2874.