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Vertebroplasty Still Shown Ineffective in Recent Trial

VERTOS IV improved upon older trial limitations, but vertebroplasty still remains a questionable treatment

A PPM Brief

Older patients (at least 50 years of age) with painful osteoporotic vertebral fractures who underwent either vertebroplasty or a sham procedure reported similar pain relief over the span of a year following surgery. The recent findings1 suggested that other factors, including local anesthesia, placebo effect, and natural healing of the fractures may have accounted for the observed clinical improvement, according to the researchers.

Percutaneous vertebroplasty, in which bone cement is injected into the fractured vertebral, has had mixed trial results and is a much-debated treatment. The procedure carries several risk complications, including spinal cord injury or pulmonary embolism from cement leakage. This recent trial aimed to improve upon limitations of previous studies2 by using stricter inclusion and exclusion criteria, larger patient cohorts, longer clinical and imaging follow-up, and no crossovers, according to the researchers.

The trial enrolled and randomized 180 outpatients at four community hospitals in The Netherlands from 2011 to 2015. Participants (mean age of 76 years, of which 76% were women) had one to three thoracolumbar fractures and pain that had started up to 6 weeks prior (later 9 weeks).

Patients rated their pain as 5 or higher on a visual analog scale (VAS). While all patients received local injections of lidocaine (1%) followed by bupivacaine (0.25%), only patients in the treated group (n = 91) received injections of bone cement, while others (n = 89) received sham injections. Patients were assessed for pain (the primary outcome), quality of life, and disability at baseline from 1 day to up to 12 months later. Pain was significantly lower than baseline (at least a 1.5 unit drop on the pain scale) in both groups, with no significant between-group differences. The researchers stated that they did not anticipate “the magnitude of the positive treatment response in the sham procedure group."

"Despite the outcome of this trial, we continue to offer vertebroplasty to a proportion of referred patients," lead researcher Cristina Firanescu, MD, radiologist at the St. Elisabeth Hospital in Tilburg, The Netherlands, concluded. “Research is warranted to prove that vertebroplasty is better than periosteal infiltration of local anesthetic in hospital inpatients, since this has never been investigated."

Last updated on: May 16, 2018
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