Evaluation of calcium sulfate paste for augmentation of lumbar pedicle screw pullout strength.

BACKGROUND CONTEXT

Many authors have evaluated the components responsible for ultimate pullout strength of pedicle screws. In these studies, one important variable has been the screw fixation. Because pedicle screw fixation has increased in popularity over recent years, so has the need for augmentation in difficult situations. Polymethylmethacrylate (PMMA) has been established as the gold standard in terms of strength of fixation but has the potential for severe complications when applied in spine surgery. Calcium sulfate is an alternative to PMMA, because it lacks the exothermic reaction, is potentially osteoconductive and is resorbed by the body in 30 to 60 days.

PURPOSE

To determine the strength of a new calcium sulfate cement in terms of pedicle screw augmentation. The purpose was to evaluate calcium sulfate versus PMMA in terms of pullout strength. PMMA was considered the gold standard in terms of strength for this experiment.

STUDY DESIGN

Lumbar vertebrae implanted with pedicle screws were subjected to axial pullout tests. The force required to cause implant failure was measured and compared for three methods of fixation.

OUTCOME MEASURES

Force to failure (Newtons) for each pedicle test was recorded and analyzed with results from similarly augmented pedicles.

METHODS

Lumbar vertebrae were harvested from four cadavers and implanted with pedicle screws. These screws were either placed in native bone or augmented with either calcium sulfate paste or PMMA. In those pedicles that had augmentation, the material was permitted to set for a minimum of 24 hours. Axial pullout tests were then performed using an MTS (Materials Testing System Corporation, Minneapolis, MN) testing machine. The screws were pulled out over a distance of up to 6 mm at 0.25 mm/sec. This rate and distance ensured failure in each case. The load to failure was recorded for each pedicle.

RESULTS

Calcium sulfate augmentation improved pedicle screw pullout strength significantly when compared with native bone (p=.0003). This represented an average increase of 167% over the native bone. Likewise, PMMA improved the pullout strength significantly over native bone (p<.0001) for an average increase of 199%. There were no significant differences between the calcium sulfate and PMMA augmentation (p=.0791), although the PMMA averaged 119% of the strength of calcium sulfate.

CONCLUSIONS

Although PMMA is considered the gold standard in terms of fixation strength, its use around the spine has been limited because of concern over complications. The calcium sulfate bone paste tested in this study demonstrated strength similar to PMMA without the major risks to the spinal cord. In addition, the calcium sulfate paste allows for possible osteoconduction to aid in spinal fusion. Further study is needed to determine the applicability of this calcium sulfate paste in the clinical setting of spine surgery.