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

Staples, M. P., Howe, B. M., Ringler, M. D., Mitchell, P., Wriedt, C. H. R., Wark, J. D., Ebeling, P. R., Osborne, R. H., Kallmes, D. F. and Buchbinder, R. 2015, New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial, Archives of osteoporosis, vol. 10, no. 26, pp. 1-10, doi: 10.1007/s11657-015-0229-0.

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Title New vertebral fractures after vertebroplasty: 2-year results from a randomised controlled trial
Author(s) Staples, M. P.
Howe, B. M.
Ringler, M. D.
Mitchell, P.
Wriedt, C. H. R.
Wark, J. D.
Ebeling, P. R.
Osborne, R. H.
Kallmes, D. F.
Buchbinder, R.
Journal name Archives of osteoporosis
Volume number 10
Issue number 26
Start page 1
End page 10
Total pages 10
Publisher Springer
Place of publication Berlin, Germany
Publication date 2015-12
ISSN 1862-3522
1862-3514
Keyword(s) Placebo-controlled
Randomised trial
Vertebroplasty
Summary Summary: 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.
Language eng
DOI 10.1007/s11657-015-0229-0
Field of Research 110314 Orthopaedics
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, Springer
Persistent URL http://hdl.handle.net/10536/DRO/DU:30077441

Document type: Journal Article
Collection: Population Health
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