Vertebral Body Stenting Versus Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures A Randomized Trial

Background: In the treatment of vertebral compression fractures, vertebral body stenting with an expandable scaffold inserted before application of the bone cement was developed to impede secondary loss of vertebral height encountered in patients treated with balloon kyphoplasty. The purpose of this study was to clarify whether there are relevant differences between balloon kyphoplasty and vertebral body stenting with regard to perioperative and postoperative findings. Methods: In a two-armed randomized controlled trial, patients with a total of 100 fresh osteoporotic vertebral compression fractures were treated with either balloon kyphoplasty or vertebral body stenting. The primary outcome was the post-interventional change in the kyphotic angle on radiographs. The secondary outcomes were the maximum pressure of the balloon tamp during inflation, radiation exposure time, perioperative complications, and cement leakage. Results: The mean reduction (and standard deviation) of kyphosis (the kyphotic correction angle) was 4.5° ± 3.6° after balloon kyphoplasty and 4.7° ± 4.2° after vertebral body stenting (p = 0.972). The mean pressures were 24 ± 5 bar (348 ± 72 pounds per square inch [psi]) during vertebral body stenting and 16 ± 6 bar (233 ± 81 psi) during balloon kyphoplasty (p = 0.014). There were no significant differences in radiation exposure time. None of the patients underwent revision surgery, and postoperative neurologic sequelae were not observed. Cement leakage occurred at twenty-five of the 100 vertebral levels without significant differences between the two intervention arms (p = 0.230). Intraoperative material-related complications were observed at one of the fifty vertebral levels in the balloon kyphoplasty group and at nine of the fifty levels in the vertebral body stenting group. Conclusions: No beneficial effect of vertebral body stenting over balloon kyphoplasty was found among patients with painful osteoporotic vertebral fractures with regard to kyphotic correction, cement leakage, radiation exposure time, or neurologic sequelae. Vertebral body stenting was associated with significantly higher pressures during balloon inflation and more material-related complications. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.