Preclinical evaluation of the Dynesys posterior spinal stabilization system: a nonhuman primate model.

Background Context: Posterior dynamic spinal stabilization systems are intended to restore near-normal biomechanical function of the spine without inducing unnatural stresses to the spinal elements or eliciting a histopathological response. These devices must resist loosening within the challenging biomechanical environment of the lumbar spine.

Purpose: To determine the biomechanical effects of the Dynesys dynamic stabilization system (Zimmer, Inc., Warsaw, IN, USA) in the acute postoperative period and after 6 and 12 months in vivo; to examine the facet joints at the same postoperative intervals for signs of degeneration; and to measure the incidence of screw loosening after in vivo loading.

Study Design/setting: This was an in vitro and in vivo animal survival study.

Methods: Fourteen baboons were used. Eight animals underwent survival surgery to implant a posterior dynamic stabilization system spanning two lumbar levels. Six animals were sacrificed acutely, and their spines were biomechanically tested in the intact condition and with instrumentation implanted as described above. Six animals in the survival group were sacrificed at 6 months postoperatively and two animals at 12 months postoperatively. Their spines were biomechanically tested with instrumentation in situ and explanted. The facets were then processed using undecalcified technique. Microradiographs of the facets were examined for signs of arthrosis, inflammation, and degenerative changes.

Results: The range of flexion-extension motion for the acute group of instrumented spines was 27% of the intact condition. After 6 months with instrumentation in situ, flexion-extension was 56% of the intact condition. After 12 months with instrumentation in situ, flexion-extension was 70% of the intact condition. With instrumentation explanted, flexion-extension at 6 and 12 months was not different from the intact condition (p>.05). Similar results were observed for lateral bending. There were no significant differences in axial rotation between any groups at any time point (p>.05). The facet joints at the operative and adjacent levels exhibited normal articular cartilage at both the 6- and 12-month postoperative time points. There was no evidence of facet arthrosis in any animal. At 6 months postoperatively, 0 of 36 screws exhibited radiolucency at the bone-metal interface. At 12 months postoperatively, 3 of 12 screws exhibited radiolucency.

Conclusions: After 12 months in vivo, spinal motions were stabilized by the dynamic instrumentation system. No facet arthrosis was observed at 6 and 12 months postoperatively. Explantation of the instrumentation restored motion to intact levels. A 25% rate of screw loosening (3 of 12 screws) was observed at the 12-month postoperative time point.