Osteoporotic fracture: vertebroplasty found ineffective in VERTOS IV

  • BMJ

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • Vertebroplasty (vs sham procedure) is ineffective for treating painful acute osteoporotic vertebral compression fractures, according to a randomized double-blind clinical trial.

Why this matters

  • Results fail to support vertebroplasty in treatment of acute osteoporotic vertebral compression fractures.

Study design

  • Randomized, double-blind, sham-controlled, multicenter clinical trial of 180 patients randomly assigned to vertebroplasty (n=91) or sham procedure (n=89) in VERTOS IV.
  • Both groups received local subcutaneous lidocaine and bupivacaine at each pedicle, after which the vertebroplasty group received cementation whereas the sham group received simulated cementation.
  • Main outcome was pain reduction by visual analog scale (VAS).
  • Secondary outcomes were QoL (QoL questionnaire of the European Foundation for Osteoporosis) and disability (Roland-Morris Disability Questionnaire).
  • Patients were studied at baseline, 1 day, and 1 week, and at 1, 3, 6, and 12 months.
  • Funding: Stryker.

Key results

  • No difference in VAS was seen at all points.
  • No difference in QoL and disability was seen at all points.
  • Both groups had decreased use of analgesics (nonopioids, weak opioids, strong opioids) at all points after procedure.
  • The vertebroplasty group had 2 adverse events: respiratory insufficiency and vasovagal reaction.

Limitations

  • Study lacked an additional control group receiving conservative management.

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