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Word of the Day

Vertebroplasty no more effective than sham treatment for compression fracture

Clinical Question:
In patient with severe pain or pain of recent onset due to vertebral compression fracture, is vertebroplasty more effective than sham treatment to decrease pain and improve function?

Bottom Line:
Vertebroplasty will cause marked improvement in pain and disability scores in approximately half the patients who undergo this procedure. So, too, will a sham procedure that does everything except inject the bone cement. So, vertebroplasty is effective; it's just not more effective than a fake procedure. It also exposes patients to the risks of surgery and is more likely to result in long-term opioids use. (LOE = 1a)

Reference:
Staples MP, Kallmes DF, Comstock BA, et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ 2011;343:d3952.  [PMID:21750078]

Study Design:
Meta-analysis (randomized controlled trials)

Funding:
Self-funded or unfunded

Setting:
Various (meta-analysis)

Synopsis:
It's a rare find -- 2 randomized placebo-controlled trials of a surgical procedure. These authors combined the results of the 2 studies of vertebroplasty in 209 patients with at least 1 confirmed vertebral compression fracture of less than 12 months' duration; 27% had recent onset of pain and 47% had severe pain at baseline. Both studies masked patients, investigators, and outcome assessors (but not, of course, the proceduralists) to treatment, which consisted of either vertebroplasty or a sham procedure that mimicked the real procedure except for the actual injection of the cement, down to preparing the cement in the room so the smell of the procedure would be same. One month following the procedure, 54% of patients achieved at least a 3-unit improvement in pain and disability. A similar proportion, however, also improved on both measures in the placebo group. Responses were similar to real and sham treatment in both the recent onset and severe pain groups. Patients receiving vertebroplasty were more likely to be using an opioid at 1 month.

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