Older patients with one to three recent painful osteoporotic vertebral fractures who had 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,” say Cristina E Firanescu, MD, from St. Elisabeth Hospital in Tilburg, the Netherlands, and colleagues.
Their findings, from the VERTOS IV trial, were published online May 9 in BMJ.
The work suggests “that factors aside from instillation of polymethylmethacrylate [bone cement] might have accounted for the observed clinical improvement after vertebroplasty; for example, the effect of local anesthesia, expectations of pain relief (placebo effect), [and] natural healing of the fracture,” according to the researchers.
All patients received a local anesthetic before being randomized to vertebroplasty or a sham procedure.
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 [of local anesthetic] 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.”
Writing in an accompanying editorial, Evan Davies, BM, a spinal surgeon at Southampton General Hospital, UK, agrees. “This trial suggests that vertebroplasty should not be offered to patients with three or fewer painful osteoporotic vertebral fractures of less than 6 to 9 weeks’ duration,” he writes.
“Local anesthetic injections,” he notes, “seem cheaper, are likely safer, and equally beneficial.”
Most patients with fragility fractures receive conservative treatment, and even those with severe pain normally improve within 6 weeks, he notes.
“Early vertebroplasty — before 9 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
Osteoporotic vertebral compression fractures are painful and can lead to deformity, breathing problems, and loss of height. Conservative management includes opioids and other analgesics, bed rest, and a back brace.
Percutaneous vertebroplasty, in which a bone cement is injected into the fractured vertebral body, became a widely used treatment starting in the 1990s, but trial results have been mixed, and despite endorsement by some professional societies, use of the procedure remains a subject of debate.
As reported earlier, in 2009, two blinded randomized trials of patients with osteoporotic compression fractures did not find better 1-month or 3-month pain relief with vertebroplasty versus a sham procedure.
But in 2010 and 2015, the unblinded VERTOS II and VAPOUR trials, respectively, reported that vertebroplasty was better than sham.
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)
Firanescu and colleagues say that, with this trial design, they intended to improve upon limitations of the 2009 trials by using stricter inclusion and exclusion criteria, larger patient cohorts, longer clinical and imaging follow-up, and no crossovers.
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.
However, only patients in the treated group (n = 91) received injections of bone cement; the others (n = 89) received sham injections.
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), 1 day, 1 week, and 1, 3, 6, and 12 months later.
Pain was significantly lower than baseline (a drop of at least 1.5 units on the pain scale) at all time points in both groups, with no significant between-group differences.
For example, from baseline to 1 month to 12 months, mean pain scores declined from 7.72 to 3.32 to 2.72 in the treated group and from 7.92 to 3.73 to 3.17 in the sham-procedure group.
The mean 12-month change in pain score of 5.00 in the treated group versus 4.75 in the sham-procedure group was not statistically different (P = .48).
There were also no significant between-group differences in quality of life or disability at any time point.
The use of strong or weak opioids or other painkillers also dropped significantly in both groups, with no significant between-group difference.
There were two adverse events, both in the vertebroplasty group: one patient had respiratory insufficiency and another had a vasovagal reaction.
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%).
“We did not anticipate the magnitude of the positive treatment response in the sham procedure group,” the researchers admit.
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.
And the VAPOUR trial — which did show a benefit — included predominantly hospitalized inpatients (57%) with more severe pain (≥ 7 on a scale of 1 to 10) for a shorter time (about 2.6 weeks), and the sham-treatment group did not receive anesthetic injections at the pain sites.
Research is warranted “to prove that vertebroplasty is better than periosteal infiltration of local anesthetic in hospital inpatients, since this has never been investigated,” stress the researchers.
And 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, Davies concluded.
The research was supported by Stryker. The authors have reported no relevant financial relationships.
BMJ. Published online May 9, 2018. Full text, Editorial
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