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Early vertebroplasty within 3 weeks of fracture for acute painful vertebral osteoporotic fractures: subgroup analysis of the VAPOUR trial and review of the literature

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Abstract

Background

VAPOUR found vertebroplasty (V) more effective than placebo (P) in patients with severe pain and fracture duration less than 6 weeks. Exploratory analysis suggested that benefits were concentrated in the subgroup of patients with fractures ≤ 3-week duration. This difference may account for the three negative blinded trials that included few patients within this fracture time frame.

Purpose

To assess the safety and efficacy of early vertebroplasty for acute painful vertebral osteoporotic fractures within 3 weeks of fracture onset in the VAPOUR study.

Methods

Spearman’s rank log coefficients were calculated to reassess the relationship of pain reduction from vertebroplasty and fracture duration in the VAPOUR trial. We more fully report baseline and outcome data in patients with fractures ≤ 3-week duration.

Results

There were 46V and 47P patients with fractures ≤ 3-week duration. Baseline characteristics were similar. In total, 86 patients (41V, 45P) completed the 14-day questionnaire. The proportion of patients with reduction in pain from severe (NRS ≥ 7/10 was an inclusion requirement) to mild (NRS < 4) at 14 days was 21 (51%) V-group and 9 (20%) in the P-group (between-group difference 31 percentage points, 95% CI 12–50; p = 0.002). Early vertebroplasty provided greater reductions in mean NRS pain and Roland–Morris Disability.

Conclusion

Analysis of this patient subgroup from the VAPOUR trial, in the context of other randomised trial evidence, suggests clinically significant benefits from early vertebroplasty if performed within 3 weeks of fracture.

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Funding

No funds were received in support of this work.

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Authors and Affiliations

  1. St George and Sutherland Clinical School UNSW, St George Hospital, Sydney, NSW, Australia

    Terrence Diamond & Paul Bird

  2. Interventional Radiology, St George Private Hospital, Sydney, NSW, Australia

    William Clark

  3. School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia

    Peter Gonski

  4. NHMRC Clinical Trial Centre, University of Sydney, Sydney, NSW, Australia

    Elizabeth Barnes & Val Gebski

Authors
  1. Terrence Diamond
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  2. William Clark
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  3. Paul Bird
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  4. Peter Gonski
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  5. Elizabeth Barnes
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  6. Val Gebski
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Correspondence to Terrence Diamond.

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Conflict of interest

All authors declare that there is no conflict of interest.

Ethical approval

The trial was approved by the Human Research Ethics Committees of Bellberry Limited (2011-08-414) and North Sydney Local Health District (HREC/11/HAWKE/228). The Human Research Committee at each participating centre approved the study, and all patients provided written informed consent.

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Diamond, T., Clark, W., Bird, P. et al. Early vertebroplasty within 3 weeks of fracture for acute painful vertebral osteoporotic fractures: subgroup analysis of the VAPOUR trial and review of the literature. Eur Spine J 29, 1606–1613 (2020). https://doi.org/10.1007/s00586-020-06362-2

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  • DOI: https://doi.org/10.1007/s00586-020-06362-2

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