PubMed1999
STUDY DESIGN: A mechanical testing standard for anterior thoracolumbar instrumentation systems was introduced, using a synthetic model. Twelve recent instrumentation systems were tested in static and fatigue modes. OBJECTIVES: To establish the testing standard for anterior thoracolumbar instrumentation systems using a synthetic model and to evaluate the static and fatigue biomechanical properties of 12 anterior thoracolumbar instrumentation systems. SUMMARY OF BACKGROUND DATA: Although numerous studies have been performed to evaluate the biomechanics of anterior spinal instrumentation using a cadaveric or animal tissue, problems of specimen variation, lack of reproducibility, and inability to perform fatigue testing have been pointed out. In no studies has a precise synthetic testing standard for anterior thoracolumbar instrumentation systems been described. METHODS: An ultra-high-molecular-weight polyethylene cylinder was designed according to the anatomic dimensions of the vertebral body. Two cylinders spanned by spinal instrumentation simulated a total corpectomy defect, and a compressive lateral bending load was applied. The instrumentation assembly was precisely standardized. The static destructive and fatigue tests up to 2 million cycles at three load levels were conducted, followed by the failure mode analysis. Twelve anterior instrumentation systems, consisting of five plate and seven rod systems were compared in stiffness, bending strength, and cycles to failure. RESULTS: Static and fatigue test parameters both demonstrated highly significant differences between devices. The stiffness ranged from 280.5 kN/m in the Synthes plate (Synthes, Paoli, PA) to 67.9 kN/m in the Z-plate ATL (SofamorDanek, Memphis, TN). The Synthes plate and Kaneda SR titanium (AcroMed, Cleveland, OH) formed the highest subset in bending strength of 1516.1 N and 1209.9 N, respectively, whereas the Z-plate showed the lowest value of 407.3 N. There were no substantial differences between plate and rod devices. In fatigue, only three systems: Synthes plate, Kaneda SR titanium, and Olerud plate (Nord Opedic AB, Sweden) withstood 2 million cycles at 600 N. The failure mode analysis demonstrated plate or bolt fractures in plate systems and rod fractures in rod systems. CONCLUSIONS: The biomechanical testing standard for anterior thoracolumbar instrumentation systems was successfully designed. It provided a repeatable and consistent experimental condition and controlling dimensional and surgical factors. The comparison of 12 instrumentation systems highlights the importance of mechanically balanced device design without a weak link in the development of instrumentation.