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.