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Archives of Osteoporosis

, 10:26 | Cite as

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

  • M. P. Staples
  • 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. BuchbinderEmail author
Original Article

Abstract

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.

Keywords

Vertebroplasty Placebo-controlled Randomised trial 

Notes

Acknowledgments

The authors would like to acknowledge the valuable contribution of Dr. Leigh Gray from the Department of Radiology, Mayo Clinic College of Medicine, Rochester, MN, USA. The trial was supported by grants from the Australian National Health and Medical Research Council (NHMRC) (284354), Arthritis Australia, Cabrini Institute, and Cook Australia. The Mayo Clinic received funding from NIH (R01 AR49373) for the work submitted and from Benvenue Medical, Inc. for an unrelated spine augmentation project. Rachelle Buchbinder is supported by an Australian NHMRC Senior Principal Research Fellowship.

Conflicts of interest

None.

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Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2015

Authors and Affiliations

  • M. P. Staples
    • 1
    • 2
  • B. M. Howe
    • 3
  • M. D. Ringler
    • 3
  • P. Mitchell
    • 4
  • C. H. R. Wriedt
    • 5
  • J. D. Wark
    • 6
  • P. R. Ebeling
    • 7
  • R. H. Osborne
    • 8
  • D. F. Kallmes
    • 3
  • R. Buchbinder
    • 1
    • 2
    Email author
  1. 1.Monash Department of Clinical EpidemiologyCabrini InstituteMalvernAustralia
  2. 2.Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive MedicineMonash UniversityMelbourneAustralia
  3. 3.Department of RadiologyMayo Clinic College of MedicineRochesterUSA
  4. 4.Department of Radiology, Royal Melbourne HospitalThe University of MelbourneMelbourneAustralia
  5. 5.MIA RadiologyGlen WaverleyAustralia
  6. 6.Department of Medicine (Royal Melbourne Hospital)ParkvilleAustralia
  7. 7.Department of Medicine, School of Clinical Sciences, Monash Medical CentreMonash UniversityClaytonAustralia
  8. 8.School of Health and Social DevelopmentDeakin UniversityMelbourneAustralia

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