A novel technique of intra-spinous process injection of PMMA to augment the strength of an inter-spinous process device such as the X STOP

Study Design. Biomechanical. Objective. To determine if cement injection into the spinous process will improve compression strength. Summary of Background Data. The X STOP (St. Francis Medical Technologies) has been shown to be a safe and effective means for decompressing 1- or 2-level lumbar spinal stenosis (LSS). The X STOP is indicated for LSS patients with osteoporosis, but contraindicated for patients with severe osteoporosis. In an attempt to address these LSS patients with demonstrably weaker bone, a technique to strengthen the spinous process with polymethylmethacrylate ( PMMA) injection is presented. Methods. Nine pairs of adjacent fresh frozen cadaveric lumbar vertebrae were DEXA scanned before testing. They were randomly assigned to the PMMA group and a control group. Nine of the specimens were injected with PMMA. Each spinous process was then compressed between 2 X STOPs. The testing model was designed to simulate the loading of a 2-level X STOP placement. The mean load to failure and stiffness values of the treated and untreated groups were calculated. The specimens were inspected carefully for PMMA infiltration and extrusion. Results. The mean bone mineral density (BMD) values of the control and PMMA treatment groups were 0.99 +/- 0.13 g/cm(2) and 0.98 +/- 0.10 g/cm(2), respectively; P > 0.616. The mean volume of cement injected was 2.2 +/- 0.3 cc. The mean failure load values of the control and PMMA treatment groups were 1250 +/- 627 N and 2386 +/- 1034 N, respectively; P < 0.001. The mean stiffness values of the control and PMMA treatment groups were 296 +/- 139 N/mm and 381 +/- 131 N/ mm, respectively; P > 0.059. Most specimens had flow of the cement into the laminae and some into the facet and pedicle. No PMMA was found within the spinal canal. Conclusion. This first reported technique of posterior element vertebroplasty may increase the indications and success for patients with decreased BMD who seek an interspinous implant such as the X STOP. A possible role may exist in increasing the effectiveness of such devices. However, clinical trials have yet been performed. These results demonstrate that PMMA injection in the spinous processes is effective in increasing resistance to compressive forces in an X STOP model.