Failed trial of vertebroplasty for compression fractures

updated Apr 9, 2016

Tags: treatment, mind, surgery, bad news, back pain, biomechanics, pain problems, spine, etiology, pro

PainSci summary of Buchbinder 2009?This page is one of thousands in the PainScience.com bibliography. It is not a general article: it is focused on a single scientific paper, and it may provide only just enough context for the summary to make sense. Links to other papers and more general information are provided at the bottom of the page, as often as possible. ★★★★★?5-star ratings are for sentinel studies, excellent experiments with meaningful results. Ratings are a highly subjective opinion, and subject to revision at any time. If you think this paper has been incorrectly rated, please let me know.

This is one of a pair of 2009 papers (see also Kallmes et al) presenting strong evidence that there is “no beneficial effect” to stabilizing fractured spines with injections of bone cement (vertebroplasty), a common and yet apparently dubious procedure. That evidence is backed up by major reviews published since (Buchbinder 2015, Stevenson 2014), but some contrary evidence has also been published (Shi 2012, Klazen), and it is possible vertebroplasty works better for some kinds of patients.

The frequency of this “surgery” — though it is usually performed by surgeons, it’s just an injection in a tricky spot — will probably now drop off significantly, as surgeons demonstrate that they respect the evidence (when good science casts serious doubts on the efficacy of an intervention, most doctors will stop doing it within a few years).

The evidence is also a poetic addition to the evidence that spinal fragility is not a major driver of back pain. If stabilizing the spine with cement doesn’t resolve symptoms, it strongly suggests that instability wasn’t the problem to begin with.

Strictly speaking, the only thing this evidence can tell us is that patients with osteoporotic fractures who got vertebroplasty recovered no better than those who only thought they got vertebroplasty. But we can definitely infer more from it, because the rationale for vertebroplasty has always been cave-man simple: Ooog. Verteba [sic] busted. Hurt. Thag make bone stronger. Inject glue. Ugh. Supposedly these fractures are painful because the spine is unstable — hardly an unreasonable assumption — and therefore stabilizing them will help. Except it didn’t! Not in these patients. So it’s probably not the instability that’s causing all the pain.

~ Paul Ingraham

original abstract†Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

BACKGROUND: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.

METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or >=6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.

RESULTS: A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/-SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.

CONCLUSIONS: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment.

original abstract†Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.

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