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