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Randomized kyphoplasty trial equates clinical results with improved kyphosis

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AMSTERDAM — Balloon kyphoplasty results demonstrated greater improvements in physical component summary scores compared with nonoperative management when both approaches were used to treat vertebral compression fractures, according to a presenter here at SpineWeek 2012.

“There is strong clinical evidence supporting kyphoplasty as an effective and early treatment option of patients with compression fractures. Its results are superior to nonsurgical management and the improvement persists for at least 2 years,” Jan K. van Meirhaeghe, MD, of Brugge, Belgium, said.

The report, which focused on the surgical parameters and vertebral body kyphosis correction with balloon kyphoplasty, included findings from the multicenter, randomized FREE trial conducted at centers in Belgium, Germany, Sweden and the United Kingdom. The trial’s primary endpoint was the SF-36 physical component summary (PCS) score at 1 month postoperatively. Surgical parameters and radiological results were among the secondary endpoints in the trial, van Meirhaeghe said.

Patient satisfaction results correlated with the clinical findings. Compared to the group treated with nonsurgical care, “On a 20-point Likert scale, patients were more satisfied with the kyphoplasty procedure. The difference was statistically significant at all time points including 24 months,” van Meirhaeghe said.

Furthermore, there was a 7.4 point improvement in PCS scores for the worst kyphosis correction cases, and that PCS score improvement nearly doubled among patients with the best kyphosis repair.

“There is a correlation between the improvement of the kyphotic angulation and the improvement in the SF-36 quality of life,” Van Meirhaeghe said.

Based on the radiological findings, there was a statistically significant postoperative deformity correction of 3.3°, which was maintained during the follow-up period. Many patients had even greater correction, as well as anterior vertebral height restoration, he said.

However, van Meirhaeghe put these positive findings in the overall context of a surgical trial, saying the rate of cement leakage with kyphoplasty was 27%, although it was not into the spinal canal or foramen, and patients were asymptomatic. Most adverse events could be attributed to patient positioning, anesthesia or catheterizations during kyphoplasty surgery, he said.

“Review of the safety data suggests care in preparing patients for surgery and positioning them on the operating table,” van Meirhaeghe said.

Reference:

• van Meirhaeghe J ,  Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and non-surgical management for treating acute vertebral compression fractures: Vertebral body kyphosis correction and surgical parameters. Paper #221. Presented at SpineWeek 2012. May 28-June 1. Amsterdam.
• Disclosure: van Meirheaghe listed Synthes and Medtronic as disclosures.