Abstract
BACKGROUND: Extrusion is a known complication of lumbar nucleus replacement devices. Despite this fact, this complication has not been well studied in an in vitro cadaveric model under fatigue-loading conditions. METHODS: Lumbar constructs (with treated and control levels) were tested in intact, postdisectomy, and postnucleus implant conditions under compression, torsion, and bending for initial biomechanical assessment. Constructs were then tested for 100(k) cycles under fatigue loading to assess extrusion risk. Potential adverse effects to vertebral and endplate fractures were assessed using gross dissection and macroscopic and micro-computed tomography evaluation techniques. RESULTS: Based on the initial biomechanical assessment, implantation of the nucleus device significantly increased disc height compared with the discectomy condition, and there were no significant differences between the intact and implanted conditions for range of motion or stiffness. All constructs completed the 100(k) cycles with no extrusions. There was evidence of implant shift toward the right lateral annulus on postfatigue images. Postfatigue dissection and imaging showed no evidence of macroscopic endplate or trabecular fractures. CONCLUSION: Using a 2-level lumbar in vitro construct, the biomechanical function of the treated level with an articulating nucleus implant was similar to intact. In vitro fatigue testing showed no implant extrusion and macroscopic changes to the bony structure or cartilaginous endplates when comparing treated and intact levels.