Osteoporotic vertebral fractures affect hundreds of thousands of elderly in the United States every year. Conservative management, with bed rest, bracing, analgesics and physical therapy, is the mainstay of treatment but interventional vertebral body augmentation has become more popular and controversial over the past 2 decades. Recent highly publicized studies have found no difference in improvement with sham surgery versus actual bone augmentation, but critics cite that many chronic fractures (greater than 3 months, some up to 1 year) were included in these studies which may have skewed results. Early intervention may be an important factor in achieving better clinical results and to this end, one recent study of kyphoplasty for fractures less than 1 month old (FREE study) showed improved results with bone augmentation versus conservative therapy. Kyphoplasty, however, has a higher fixed cost than vertebroplasty and finding any substantive difference between the two procedures has been elusive.
Vertos II is a multi-center, randomized trial conducted in the Netherlands and Belgium comparing vertebroplasty and conservative therapy in acute vertebral compression fractures (Lancet 2010;376:1085-1092). Six different centers (departments of radiology) identified 431 eligible patients, 53% of which had resolution of symptoms prior to beginning treatment. Patients were 50 years of age or older, had compression fractures at T5 or lower of at least 15% loss of height and edema on magnetic resonance imaging (MRI) scan, less than 6 weeks of symptoms and a visual analogy scale (VAS) score of 5 or more. Of the 202 patients enrolled, 101 patients were randomized in blocks to vertebroplasty or conservative treatment. Primary outcome was VAS pain score at 1 month and 1 year with intention to treat analysis.
Vertebroplasty resulted in greater pain relief than conservative therapy at both 1 month and 1 year. VAS score was 2.6 points lower for vertebroplasty at 1 month and 2.0 points lower at 1 year (P < .0001). An average of 1.3 levels were augmented in the vertebroplasty group with and average of 4.1 ml injected into each level. Average time from onset of symptom to vertebroplasty was 5.6 weeks. Cross-over was low (6% for vertebroplasty arm and 10% in conservative arm) and drop out rates were low (83% follow up at 1 year). Complications from vertebroplasty were also low and occurrence of new fractures during follow up was similar in both groups. Cost effectiveness analysis performed estimated a €22 685 cost per quality adjusted life-year (QALY) gained.
Vertos II is the first class I study which shows a benefit to vertebroplasty compared to conservative treatment for acute fractures less than 3 months old. Though a previous study comparing kyphoplasty showed similar results, vertebroplasty offers a lower fixed cost to the procedure than kyphoplasty. Cost is an increasing obstacle in treating compression fractures with surgery as reimbursement for such procedures is being curtailed.
Timing of intervention for osteoporotic compression fractures may indeed play in role in its ultimate benefit, which is this study's most interesting result. Multiple studies have already shown that intervention is beneficial compared to non-intervention, and this corroborates that evidence. This study was funded by Cook Medical, whose devices were used for the vertebroplasty arm, but the authors disclose no other financial conflicts and that the results were not censored in any way.
Figure. Kaplan Meier...Image Tools
John H. Chi