Clinical evaluation of a bone cement-injectable cannulated pedicle screw augmented with polymethylmethacrylate: 128 osteoporotic patients with 42 months of follow-up
OBJECTIVES: To evaluate the safety and efficacy of a novel bone cement-injectable cannulated pedicle screw augmented with polymethylmethacrylate in osteoporotic spinal surgery. METHODS: This study included 128 patients with osteoporosis (BMD T-score –3.2±1.9; range, –5.4 to –2.5) who underwent spinal decompression and instrumentation with a polymethylmethacrylate-augmented bone cement-injectable cannulated pedicle screw. Postoperative Visual Analogue Scale scores and the Oswestry Disability Index were compared with preoperative values. Postoperative plain radiographs and computed tomography (CT) scans were performed immediately after surgery; at 1, 3, 6, and 12 months; and annually thereafter. RESULTS: The mean follow-up time was 42.4±13.4 months (range, 23 to 71 months). A total of 418 polymethylmethacrylate-augmented bone cement-injectable cannulated pedicle screws were used. Cement extravasations were detected in 27 bone cement-injectable cannulated pedicle screws (6.46%), mainly in cases of vertebral fracture, without any clinical sequela. The postoperative low back and lower limb Visual Analogue Scale scores were significantly reduced compared with the preoperative scores (o0.01), and similar results were noted for the Oswestry Disability Index score (po0.01). No significant screw migration was noted at the final follow-up relative to immediately after surgery (po0.01). All cases achieved successful bone fusion, and no case required revision. No infection or blood clots occurred after surgery. CONCLUSIONS: The polymethylmethacrylate-augmented bone cement-injectable cannulated pedicle screw is safe and effective for use in osteoporotic patients who require spinal instrumentation.