Among patients with acute osteoporotic vertebral compression fractures, vertebroplasty reduced pain more than medical therapy, an open-label randomized trial showed.
Patients who underwent vertebroplasty charted significantly greater reductions in the 10-point visual analog scale score at both one month and one year than those under conservative management (P<0.0001 for both), Caroline Klazen, MD, of St. Elisabeth Hospital in Tilburg, the Netherlands, and colleagues reported online in The Lancet.
From baseline, the reductions in pain in the vertebroplasty group were 5.2 and 5.7 points at the two time points, which exceeded the 3-point reduction needed to be considered clinically meaningful, according to the researchers.
The reductions in the control group were less substantial at 2.7 and 3.7 at one month and one year, respectively.
Although vertebroplasty was more expensive, Klazen and her colleagues said the added cost was acceptable assuming society is willing to pay €30,000 ($39,687) per quality-adjusted life-year.
The study “lends support to the large body of medical opinion that vertebroplasty has a part to play in the management of the pain of vertebral compression fractures,” Douglas Wardlaw, MBMhB, of Woodend Hospital in Aberdeen, Scotland, and Jan Van Meirhaeghe, MD, of St. Jans General Hospital in Brugge, Belgium, wrote in an accompanying editorial.
The findings are at odds with two studies published last year in the New England Journal of Medicine that found vertebroplasty was no better than a sham procedure for controlling pain.
At the time, several researchers noted methodological limitations of those studies, including some highlighted by Klazen and her colleagues.
Those included the use of patients with subacute and chronic fractures up to a year old, the absence of a control group that did not get an intervention, and inconsistent use of the evidence of bone edema on MRI as an inclusion criterion.
In the current study — Vertos II — patients at six hospitals in the Netherlands and Belgium were included if they had radiographic evidence of acute osteoporotic vertebral compression fractures with back pain that had been ongoing for no more than six weeks and evidence of bone edema on MRI.
Entry required a minimum visual analog score of 5.
Of 431 patients 50 and older (mean age 75) eligible for randomization, 229 (53%) had spontaneous pain relief during assessment and were not included.
The remaining 202 patients were assigned to vertebroplasty or conservative treatment. All received analgesia, bisphosphonates, calcium supplementation, and vitamin D.
Among patients in the control group, 10 requested and received vertebroplasty during follow-up.
Of the treated vertebrae, 72% had cement leakage, although all patients remained asymptomatic.
The greater pain relief in the vertebroplasty group became apparent as early as one day after the procedure and was sustained through the end of the one-year follow-up period.
The use of pain medication was significantly reduced in the vertebroplasty group at one day, one week, and one month (P<0.05), but not at later time points.
Improvements in quality of life and disability were significantly greater with vertebroplasty (P<0.0001 for both).
The researchers reported no serious complications or adverse events. The rate of new fractures did not differ between the groups.
Vertebroplasty was more expensive than conservative treatment by €2,474 ($3,272) at one month and €2,450 at one year. The difference was roughly equal to the cost of the procedure (€2,463).
The adjusted trial-based incremental cost-effectiveness ratio for vertebroplasty compared with conservative treatment was €22,685 (about $30,000) per quality-adjusted life-year gained, which the researchers called acceptable in their paper.
They noted some limitations, however, including the inability to mask treatment assignment and a mean delay of nine days before vertebroplasty was performed.
In their editorial, Wardlaw and Van Meirhaeghe noted that balloon kyphoplasty — which creates a space in the fractured vertebra with a balloon before injecting the cement — has also been shown to be effective for osteoporotic vertebral compression fractures.
Four studies that compare vertebroplasty and balloon kyphoplasty are underway, they noted.
“Their findings are expected to elucidate further the long-term outcome of these procedures in a time when the size of the aging population is growing.”