Kallmes et al (2009) | Buchbinder et al (2009) | VAPOUR trial (2016) | |
Enrolment | 131 | 78 | 120 |
Fracture duration | <12 months | <12 months | <6 weeks |
Mean fracture duration weeks (SD) | 23 (16) | 12 (11) | 3 (2) |
NRS pain requirement | >3/10 | Not specified | ≥7/10 |
Mean NRS pain baseline (SD) | 7.0 (1.9) | 7.3 (2.2) | 8.6 (1.2) |
Hospitalised patients (before enrolment) % | 0 | Not reported | 57 |
Placebo | Simulated vertebroplasty | Simulated vertebroplasty | Simulated vertebroplasty |
Masking analysis? | Yes | No | Yes |
Crossover permitted? | Yes at 1 month | No | No |
Primary endpoint | Mean NRS pain 1 month | Mean NRS pain 3 months | % NRS pain <4/10 at 2 weeks |
Trial outcome | No evidence of benefit for vertebroplasty | No evidence of benefit for vertebroplasty | Vertebroplasty superior to placebo |
NRS, numeric rated scale.