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A comparison of the published prospective multicenter sham procedure RCTs on vertebroplasty for osteoporotic fractures
Trials of Buchbinder et al23,26 INVEST24 VAPOUR33 Total enrollment (No.) 78 131 120 Age (yr) inclusion threshold None 50 60 Mean (SD) age (yr) 76.6 (12.1) 73.8 (9.4) 80.5 (7) NRS pain score inclusion threshold None ≥3 ≥7 No. (%) with severe pain 38 (49%) NRS ≥8/10 61 (47%) NRS ≥8/10 120 (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-weeks 31 (40%) 26 (20%) 120 (100%) Advanced imaging (MRI or SPECT/CT) required? Yes No Yes Hospitalized patients NR 0 57% Mean (SD) PMMA volume (mL) 2.8 (1.2) NR 7.5 (2.8) Primary end point Mean NRS pain at 3 mo Mean NRS pain at 1 mo % NRS pain <4/10 at 2 wk Primary outcome No difference No difference Vertebroplasty superior
Note:—NR indicates not reported.