Biomechanical evaluation of a new total posterior-element replacement system

Study Design. In vitro study to characterize the flexibility of a new total posterior-element system when instrumented to L4-L5 segments. Objective. The goal of this in vitro study was to investigate whether an optimized version of the TOPS implant (Impliant Ltd., Ramat Poleg, Israel) is capable to restore the physiologic motion characteristic of a spinal segment after facetectomy. Summary of Background Data. The TOPS implant is designed to replace the posterior elements of a functional spinal unit, to provide flexible restabilization and spinal alignment, while maintaining the intervertebral disc. The implant is composed of bilateral pedicle screws, connected with 2 crossbars in the transversal plane. The crossbars are joined together by an elastic element capable of transmitting tensile and compressive loads, as well as shear forces. Methods. Six human cadaver specimens (L3-S1) (median age 61 years: minimum 47 and maximum 74 years) were used for this in vitro experiment. The specimens were loaded with pure moments of +/- 7.5 Nm in flexion/extension, lateral bending, and axial rotation. The following states were investigated: (1) intact; (2) after bilateral laminectomy, including facetectomy of the lower facet joints, of the upper vertebra L4; and (3) after device implantation. The range of motion (ROM), neutral zone, and intradiscal pressure were determined from a third cycle. In a second step, the ROM in axial rotation was determined as a function of different flexion/extension postures. Results. In the neutral position, the laminectomy and facetectomy increased the median values of the ROM in flexion plus extension, lateral bending right plus left, and significantly in axial rotation left plus right from: 8.2 degrees, 7.6 degrees, 3.6 degrees to 12.1 degrees, 8.5 degrees, and 8.5 degrees (Wilcoxon signed rank test; P < 0.05). After fixation of the implant, the ROM was again reduced to 6.8 degrees, 7.8 degrees, and 3.8 degrees. In a flexed posture, the ROM in axial rotation was slightly increased compared to the neutral position. With increasing extension, the axial rotation decreased linearly from 3.7 degrees in neutral position to 2.3 degrees in 4 degrees extension in the segment L4-L5. The characteristic of the intradiscal pressure versus load with the implant was similar to that of the intact specimen. Conclusion. The TOPS implant almost ideally restored the ROM in lateral bending and axial rotation compared to that of the intact specimen. In the sagittal plane, 85% of the intact ROM could be obtained. The ROM in axial rotation as a function of flexion and extension angle also mimics the biomechanical behavior of the posterior complex of a lumbar spine. This relationship between ROM and posture emphasizes the importance of a proper implantation.