Abstract
Background Semirigid spine fixation systems utilizing nonmetallic materials have emerged as a promising innovation to overcome the inherent disadvantages of metal instrumentation in spine surgery. This study tests the mechanical properties of a novel spine fixation system made entirely of carbon-fiber-reinforced PEEK (CFR-PEEK) composite material (CarboClear System, CarboFix Orthopedics Ltd., Israel). Methods An in vitro mechanical evaluation of the CFR-PEEK CarboClear system was conducted in compliance with the American Society for Testing and Materials (ASTM) F1717, F2193, and F543 standards. Results The mean bending yield load, bending ultimate load, and bending stiffness of the construct were 322 N, 363 N, and 45 N/mm, respectively. All tested samples completed 5 × 106 dynamic cycles successfully, with no evidence of fatigue failure at increasing load levels, up to 83% of ultimate bending load. The mean torsional stiffness was 1.0 Nm/deg and the mean screw axial pull-out strength was 2,037 N. Conclusion The CarboClear Pedicle Screw System has mechanical properties comparable to those of other commonly used titanium-made systems, with superior fatigue properties. The fatigue resistance, modulus of elasticity which is very similar to that of bone, radiolucency, and CT/MRI artifact-free feature of this spine fixation system made entirely of CFR-PEEK may offer advantages over traditional spine fixation systems made of metal alloys.
Highlights
Semirigid spine fixation systems utilizing nonmetallic materials have emerged as a promising innovation to overcome the inherent disadvantages of metal instrumentation in spine surgery. is study tests the mechanical properties of a novel spine fixation system made entirely of carbon-fiber-reinforced PEEK (CFR-PEEK) composite material (CarboClear System, CarboFix Orthopedics Ltd., Israel)
Conclusion. e CarboClear Pedicle Screw System has mechanical properties comparable to those of other commonly used titanium-made systems, with superior fatigue properties. e fatigue resistance, modulus of elasticity which is very similar to that of bone, radiolucency, and CT/MRI artifact-free feature of this spine fixation system made entirely of CFRPEEK may offer advantages over traditional spine fixation systems made of metal alloys
It has been shown that orthopedic implants made of CFR-PEEK composite, with carbon fibers fraction of approximately 60% by volume, have mechanical properties equivalent to that of cortical bone with promising results in spine surgery [11,12,13,14]
Summary
Semirigid spine fixation systems utilizing nonmetallic materials have emerged as a promising innovation to overcome the inherent disadvantages of metal instrumentation in spine surgery. is study tests the mechanical properties of a novel spine fixation system made entirely of carbon-fiber-reinforced PEEK (CFR-PEEK) composite material (CarboClear System, CarboFix Orthopedics Ltd., Israel). Is study tests the mechanical properties of a novel spine fixation system made entirely of carbon-fiber-reinforced PEEK (CFR-PEEK) composite material (CarboClear System, CarboFix Orthopedics Ltd., Israel). An in vitro mechanical evaluation of the CFR-PEEK CarboClear system was conducted in compliance with the American Society for Testing and Materials (ASTM) F1717, F2193, and F543 standards. It has been shown that orthopedic implants made of CFR-PEEK composite, with carbon fibers fraction of approximately 60% by volume, have mechanical properties (e.g., modulus of elasticity and fatigue strain) equivalent to that of cortical bone with promising results in spine surgery [11,12,13,14]. E CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd., Herzliya, Israel) is a novel spine fixation system composed entirely of CFR-PEEK composite (i.e., rods and pedicle screws). A constant tensile load was applied at a rate of 5 mm/min along the axis of the screw until the screw was released from the test block or broke (Figure 5)
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