Table 2. Descriptive comparison of Barricaid device results through three months in postmarket study vs. FDA-regulated RCT.
ODI, Oswestry Disability Index; RCT, randomized controlled trial.
| Characteristic | Postmarket Study (n=55) | FDA-regulated RCT (n=272) |
| Baseline patient characteristics | ||
| Age, yr | 41±13 | 43±11 |
| Male sex, % | 60% | 57% |
| Body mass index, kg/m2 | 29±4 | 26±4 |
| Index level, % | ||
| L2-L3 | 0% | 1% |
| L3-L4 | 0% | 3% |
| L4-L5 | 49% | 45% |
| L5-S1 | 51% | 51% |
| Leg pain severity | 83±14 | 81±15 |
| ODI | 58±15 | 59±12 |
| Outcomes through 3 months follow-up | ||
| Mean percent reduction in leg pain severity | 92% | 87% |
| Mean percent reduction in ODI | 79% | 74% |
| Symptomatic reherniation | 3.6% | 2.3% |
| Reoperation | 1.8% | 1.9% |