NEW YORK (Reuters Health) – Injecting bone cement into acute osteoporotic compression fractures leads to almost immediate and long-lasting pain relief – and at reasonable cost, a European group reports.
This type of percutaneous vertebroplasty is being increasingly used but its cost-effectiveness and safety have been unclear, Dr. Caroline A. H. Klazen of St Elisabeth Ziekenhuis in Tilburg, Netherlands, and colleagues said in their report, published online August 10th in The Lancet.
To confirm that this approach has additional value compared with optimum pain treatment, the research team assessed 431 patients with recent-onset (not longer than 6 weeks) back pain. During the screening process, 229 subjects had spontaneous pain improvement; the researchers randomized the remaining 202 with persistent pain to receive either vertebroplasty or conservative treatment.
The primary outcome was pain relief at 1 month and 1 year, measured with a 0-to-10 visual analog score (VAS). Baseline VAS scores were 7.8 in the vertebroplasty group and 7.5 in the conservative treatment groups. Corresponding scores were 3.7 and 6.7 one day after the procedure (p < 0.0001), 2.5 and 4.9 at 1 month (p < 0.0001), and 2.2 and 3.8 at 1 year (p < 0.014).
“The difference between treatments in mean total medical costs per patient was 2474 Euros (about US$3279) at 1 month and 2450 Euros (about US$3247) at 1 year, in favor of conservative treatment,” the investigators report. They calculate, based on the gain of 120.3 pain-free days in the first year, that “the adjusted trial-based incremental cost-effectiveness ratio for vertebroplasty, as compared with conservative treatment, was 22,685 Euros (US$30,064) QALY gained.”
The authors contrast percutaneous vertebroplasty to kyphoplasty, which involves the insertion of an inflatable tamp to create a space for injection of cement into the vertebral body. Vertebroplasty is done on an outpatient basis with local analgesia whereas kyphoplasty requires general anesthesia and hospital admission, with much higher procedural costs.
Overall, Dr. Klazen and colleagues conclude, “In a selected subgroup of patients with acute osteoporotic vertebral fractures and persistent pain, vertebroplasty is effective and safe. Pain relief after the procedure is immediate, sustained for 1 year, and is significantly better than that achieved with conservative treatment and at acceptable costs.”
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