A Novel Spine Fixation System Made Entirely of Carbon-Fiber-Reinforced PEEK Composite: An In Vitro Mechanical Evaluation.

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.