- 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.
- 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.
- 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.
- Study lacked an additional control group receiving conservative management.