A comparison of the published prospective multicenter sham procedure RCTs on vertebroplasty for osteoporotic fractures

Trials of Buchbinder et al23,26INVEST24VAPOUR33
Total enrollment (No.)78131120
Age (yr) inclusion thresholdNone5060
Mean (SD) age (yr)76.6 (12.1)73.8 (9.4)80.5 (7)
NRS pain score inclusion thresholdNone≥3≥7
No. (%) with severe pain38 (49%) NRS ≥8/1061 (47%) NRS ≥8/10120 (100%) NRS ≥7/10
Fracture age (wk) threshold<52<52<6
Mean (SD) fracture age (wk)11.7 (11.1)22.5 (16.3)3 (2)
No. (%) fractures <6-weeks31 (40%)26 (20%)120 (100%)
Advanced imaging (MRI or SPECT/CT) required?YesNoYes
Hospitalized patientsNR057%
Mean (SD) PMMA volume (mL)2.8 (1.2)NR7.5 (2.8)
Primary end pointMean NRS pain at 3 moMean NRS pain at 1 mo% NRS pain <4/10 at 2 wk
Primary outcomeNo differenceNo differenceVertebroplasty superior
  • Note:—NR indicates not reported.