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More pain reduction seen in patients with osteoporotic spine fractures after vertebroplasty vs placebo
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Results from this multicenter, randomized, double-blind, placebo-controlled study published in The Lancet indicated vertebroplasty, when compared with a placebo control procedure, was more efficient in pain reduction from osteoporotic spinal fractures that were less than 6 weeks old.
“In properly selected osteoporotic patients with a painful [vertebral compression fracture] VCF, percutaneous vertebroplasty outperformed a true sham control,” Joshua Hirsch, MD, past president of the Society of NeuroInterventional Surgery and director of Interventional and Endovascular Neuroradiology, at Massachusetts General Hospital, Harvard Medical School, in Boston, told Spine Surgery Today.
“Vertebroplasty (and its cousin kyphoplasty) have been shown on multiple occasions to outperform conservative management in a variety of ways. The 2009 active control sham studies demonstrated limited benefit to vertebroplasty. However, the active control sham is not possible in clinical practice (because of the blinding). Patients have thus not always had the opportunity to find out more about vertebroplasty when it could have been a better option that the conservative care approach that might have been used in their treatment,” Hirsch said.
Hirsch and colleagues studied patients who underwent vertebroplasty at four Sydney hospitals. They used the National Health and Medical Research Council automated randomization service to randomize 61 patients to vertebroplasty and 59 patients to placebo treatment. At enrollment, the patients had one or two osteoporotic vertebral fractures and Numeric Rated Scale (NRS) back pain scores that were 7 of 10 points or greater.
After collecting data at baseline, the investigators collected data at 3 days, 14 days, 1 month, 3 months and 6 months postoperatively. They used NRS pain scores as the primary outcome.
Findings showed NRS scores were below 4 points within 14 days of treatment in 24 patients in the vertebroplasty group and 12 patients in the placebo group. Investigators noted one patient in each group had one serious adverse event (AE) each. The AE in the patient in the vertebroplasty group was related to the procedure and in the control group the AE reported was related to the fracture. ‒ by Monica Jaramillo
Reference:
Clark W, et al. Lancet. 2016; doi: 10.1016/S0140-6736(16)31341-1.
Disclosures: The study was funded by the unrestricted research grant from CareFusion Corporation.
Perspective
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Isador H. Lieberman, MD, MBA, FRCSC
Clark and colleagues initiated and executed a multicenter, randomized, double-blind placebo-controlled trial (RCT) investigating the efficacy of vertebroplasty in patients with acute (less than 6 weeks of symptoms) vertebral compression fractures. This is not the first RCT studying vertebroplasty and I strongly suspect not the last. This study arises from the fading wake of the two, back-to-back RCTs by Buchbinder and Kallmes published in 2009 that elevated the scrutiny by which vertebroplasty was judged. Even with the increased scrutiny, and despite the debated design flaws of the 2009 studies, vertebroplasty remained a viable and valuable treatment modality supported by other level 1 and level 2 evidence-based studies. The current study by Clark and colleagues adds further supportive evidence to the benefits of vertebroplasty and is distinct from the 2009 studies by virtue of two important study design parameters. In the Clark study, the investigators only included patients with less than 6 weeks of symptoms, mimicking real world clinical circumstances, and they dictated the use of a standard technique of “adequate vertebral fill,” which is consistent with published biomechanical evidence. In addition, they performed as close to a placebo procedure as possible. This study, I am certain, will entice others to once again resurrect the pro vs. con vertebroplasty debate.
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