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Randomized Controlled Trial
. 2015:10:229.
doi: 10.1007/s11657-015-0229-0. Epub 2015 Aug 14.

New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial

M P Staples  1 , B M Howe, M D Ringler, P Mitchell, C H R Wriedt, J D Wark, P R Ebeling, R H Osborne, D F Kallmes, R Buchbinder
Affiliations
Randomized Controlled Trial

New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial

M P Staples et al. Arch Osteoporos. 2015.

Abstract

A randomised controlled trial of vertebroplasty (VP) versus placebo assessed the effect of VP on the risk of further vertebral fractures. While no statistically significant between-group differences for new or progressed fracture risk at 12 and 24 months were observed, we observed a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Our analysis was underpowered, and further adequately powered studies are needed to be able to draw firm conclusions about further vertebral risk with vertebroplasty.

Purpose: This study seeks to assess the effect of VP on the risk of further radiologically apparent vertebral fracture within two years of the procedure.

Methods: We conducted a randomised placebo-controlled trial of VP in people with acute osteoporotic vertebral fracture. Eligible participants were randomly assigned to VP (n = 38) or placebo (n = 40). Cement volume and leakage were recorded for the VP group. Plain thoracolumbar radiographs were taken at baseline, 12 and 24 months. Two independent radiologists assessed these for new and progressed fractures at the same, adjacent and non-adjacent levels.

Results: At 12 and 24 months, radiographs were available for 45 (58 %) and 47 (60 %) participants, respectively. There were no between-group differences for new or progressed fractures: 32 and 40 in the VP group after 12 and 24 months compared with 21 and 33 in the placebo group (hazard ratio (HR) 1.80, 95 % confidence interval (CI) 0.82 to 3.94). Similar results were seen when considering only adjacent (HR (95 % CI) 2.30 (0.57 to 9.29)) and non-adjacent (HR (95 % CI) 1.45 (0.55 to 3.81) levels. In all comparisons, there was a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Within the VP group, fracture risk was unrelated to total (HR (95 % CI) 0.91 (0.71 to 1.17)) or relative (HR (95 % CI) 1.31 (0.15 to 11.48)) cement volume or cement leakage (HR (95 % CI) 1.20 (0.63 to 2.31)).

Conclusion: For patients undergoing VP, our study did not demonstrate significant increases in subsequent fracture risk beyond that experienced by those with vertebral fractures who did not undergo the procedure. However, because of the non-significant numerical increases observed, studies with adequate power are needed to draw definite conclusions about fracture risk.

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Conflict of interest statement

Conflict of Interest

Margaret Staples, Matthew Howe, Michael Ringler, Peter Mitchell, Christian Wreidt, John Wark, Peter Ebeling, Richard Osborne, David Kallmes, and Rachelle Buchbinder declare that they have no conflict of interest. The Mayo Clinic has received research funding from Benvenue Medical, Inc for an unrelated spine augmentation project.

Figures

Figure 1
Figure 1
New (A) and New or progressed (B) fractures at any site
Figure 2
Figure 2
New (A) and New or progressed (B) fractures at adjacent levels
See this image and copyright information in PMC

References

    1. Buchbinder R, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557–68. - PubMed
    1. Kallmes DF, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569–79. - PMC - PubMed
    1. Zhang Z, et al. Risk Factors for New Osteoporotic Vertebral Compression Fractures After Vertebroplasty: A Systematic Review and Meta-Analysis. J Spinal Disord Tech. 2012 - PubMed
    1. Al-Nakshabandi NA. Percutaneous vertebroplasty complications. Ann Saudi Med. 2011;31(3):294–7. - PMC - PubMed
    1. Venmans A, et al. Percutaneous Vertebroplasty and Pulmonary Cement Embolism: Results from VERTOS II. AJNR Am J Neuroradiol. 2010 - PMC - PubMed

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