VAPOUR - A Randomized-Controlled Study of Vertebroplasty for Acute Painful Osteoporotic Fractures

The Lancet (2016) 388: 1408-16

Two prior RCTs showed no benefit for vertebroplasty compared to non-surgical management of osteoporotic fractures up to 12 months after onset. The VAPOUR study is a randomized, placebo-controlled, double-blinded trial to assess effectiveness of vertebroplasty for acute fractures. 120 patients with osteoporotic fractures causing back pain rated at least 7/10 for less than six weeks in duration were randomized into either vertebroplasty (N=61) or placebo surgery (N=59) groups and followed for 6 months. The primary outcome measure was the NRS pain score <4/10 at 14 days: 44% of the vertebroplasty group had pain scores <4/10 compared to 21% in placebo group (p=0.011). Mean reduction in NRS pain score was also greater for vertebroplasty than for control patients. Analgesic consumption was reduced in the vertebroplasty group after 3 months and inpatient hospital stay was reduced by 5.5 days. Subgroup analyses showed particular benefit for those with thoracolumbar junction fractures (p=0.0012). In summary, vertebroplasty is effective at reducing pain for acute painful osteoporotic fractures in this RCT.

Justin Slavin, MD
Baltimore, MD

Excellent work. Congratulation.
Grosse Pointe, Michigan
This is an important area, given the number of procedures performed. What was the percent compression at your average level, how was the "acute" stage qualified(MRI or similar) and what additional agents were provided,either analgesic or non-such as salmon calcitonin, for the patients?