According to researchers factors aside from installation of polymethylmethacrylate might have accounted for the observed clinical improvement after vertebroplasty. Older patients with one to three recent painful osteoporotic vertebral fractures who had a vertebroplasty or a sham procedure reported similar pain relief over the following year. These results do not support percutaneous vertebroplasty as standard pain treatment in patients with acute osteoporotic vertebral compression fractures. The study was published in BMJ.

However, "despite the outcome of this trial, we continue to offer vertebroplasty to a proportion of referred patients," Firanescu and colleagues write. "We believe there is a place for vertebroplasty when efficacy outweighs the risks." But as a "pragmatic approach," they advise clinicians offer "periosteal infiltration during natural healing," and then add the bone cement procedure "only in a selected subgroup of patients with insufficient pain relief after this early phase."

"Early vertebroplasty before nine weeks should probably be considered only in exceptional circumstances for patients with vertebral osteoporotic fractures," he says, noting that the procedure carries a risk of rare but potentially catastrophic complications, including spinal cord injury or pulmonary embolism from cement leakage at the time of the procedure.

Conflicting Results With Vertebroplasty

To investigate this further, VERTOS IV enrolled and randomized 180 outpatients at four community hospitals in the Netherlands in 2011 to 2015. Participants, who were at least 50 years old, had one to three thoracolumbar fractures and focal pain that had started up to 6 weeks earlier (later extended to 9 weeks)

In the current study, patients rated their pain as 5 or higher on a visual analog scale ranging from 0 (no pain) to 10 (severe pain). They also had bone edema on MRI. Participants were a mean age of 76 years, 76% were women, and they had back pain for a median 39 days.

All patients received local injections of 1% lidocaine followed by 0.25% bupivacaine. Researchers then mixed the acrylic bone cement so that patients could hear the preparation and smell the mixture.

No Difference in Primary Outcome of Pain Between Groups

Patients were assessed for pain (primary outcome), quality of life, and disability at baseline (day of the procedure), one day, one week, and 1, 3, 6, and 12 months later. The use of strong or weak opioids or other painkillers also dropped significantly in both groups, with no significant between-group difference.

Positive Response to Sham, More Study Needed

Most participants believed that they had undergone spinal surgery and received bone cement treatment whether they did (82%) or not (81%). The current trial agrees with the two smaller, shorter earlier trials that did not find a benefit of vertebroplasty for painful acute osteoporotic vertebral compression fractures. Research is warranted to prove that vertebroplasty is better than periosteal infiltration of local anesthetic in hospital inpatients since this has never been investigated.

The author concluded that more work is also needed to study "whether cement augmentation has any role in the prevention of long-term morbidity and mortality," in painful osteoporotic vertebral fractures.