Clark W et al. Lancet 2016 Aug 17. Hirsch JA and Chandra RV. Lancet 2016 Aug 17.
The procedure benefitted some highly selected patients when performed a few weeks after vertebral fracture.
Vertebroplasty is injection of polymethylmethacrylate “cement” into a fractured vertebral body to reduce pain and disability. The popularity of this procedure declined after 2009, when two randomized, sham-controlled trials showed no benefit (NEJM JW Gen Med Sep 1 2009 and N Engl J Med 2009; 361:569 and 557). However, patients in those two trials were enrolled an average of 9 and 18 weeks, respectively, after pain onset, which raises the following question: Would patients benefit if they were treated earlier?
To address this question, Australian investigators conducted another randomized trial that involved 120 patients (mean age, 80) with vertebral fractures (61% of vertebral fractures were in “thoracolumbar” segments [T11 through L2]), pain of 1 to 6 weeks’ duration (mean, 18 days), and pain scores ≥7 on a 10-point scale. Patients received either vertebroplasty or a placebo procedure (subcutaneous infiltration with lidocaine, and activity in the procedure suite that mimicked vertebroplasty).
The primary outcome — pain score <4 at 14 days — occurred significantly more frequently in the vertebroplasty group than in the placebo group (44% vs. 21%). The difference remained significant at 6 months (69% vs. 47%). A functional disability score was significantly better with vertebroplasty than with placebo at 1, 3, and 6 months (but not earlier). In subgroup analyses, vertebroplasty was beneficial only when fracture age was <3 weeks and only for fractures at T11 through L2. Two vertebroplasty patients had serious procedural complications; two placebo patients had spinal cord compression due to fracture retropulsion during follow-up.
Vertebroplasty was superior to placebo when performed a few weeks after pain onset — but only for low-thoracic and high-lumbar fractures in patients with relatively severe pain; however, only one of every four treated patients benefitted in this study. The procedure should not be used too early (e.g., during the first week), as many patients have early improvement without vertebroplasty.