Table 1.
Reviewed literature with reported radiographic and clinical outcomes
| Authors | Design | n = | Approach | Outcomes | Duration of follow-up | % Fused rhBMP-2 | % Fused control | Clinical outcomes |
|---|---|---|---|---|---|---|---|---|
| Boden et al. (2000) | Prospective randomized | 14 | ALIF | Radiographic / clinical | 24 mo | 100.00 % | 66.66 % (autograft) | ODI improved sooner in rhBMP-2 group (3 mo). Both groups showed similar improvements at 6 mo and throughout the duration. |
| Barkus et al. (2002) | Prospective randomized. (Part 1) | 279 | ALIF | Radiographic / clinical | 24 mo | 94.50 % | 88.7 % (autograft) | At all intervals, improvements in ODI, back pain, leg pain, and neurologic status observed in both groups. |
| Burkus et al. (2006) | Prospective randomized | 131 | ALIF | Radiographic | 24 mo | 100.00 % | 81.5 % (autograft) | NR |
| Barkus et al. (2009) | (Part 2) | 130 | ALIF | Radiographic / clinical | 72 mo | 98.00 % | NR | Beginning at 6 wk. Improvements in ODI, SF-36, back pain and leg pain observed at all intervals. |
| Slosar et al. (2007) | Prospective randomized | 75 | ALIF with posterior pedicle screw fixation | Radiographic / clinical | 24 mo | 100.00 % | 89 % (allograft) | RhBMP-2 group had statistically higher ODI and NRS scores at 6 mo postop. At 1 and 2 yr, both groups had statistically significant improvements. |
| Haid et al. (2004) | Prospective randomized | 67 | Single level PLIF | Radiographic / clinical | 24 mo | 92.30 % | 77.8 % (autograft) | ODI, SF-36, back pain and leg pain scores improved at all intervals for both groups. Back pain improvements nearly double with rhBMP-2 than control at 24 mo No statistically significant difference in satisfaction. |
| Michielsen et al. (2013) | Prospective randomized | 40 | Single level PLIF with pedicle screw fixation | Radiographic / clinical | 24 mo | 100.00 % | 100.00 % | Statistical improvements in all scoring for both groups. No statistical difference between groups. |
| Dimar et al. (2006) | Prospective randomized | 98 | Single level PLIF with pedicle screw fixation | Radiographic / clinical | 24 mo | 90.60 % | 73.33 % (autograft) | No significant differences in any outcome measure at any interval. |
| Glassman et al. (2007) | Retrospective | 148 | Single level PLIF with pedicle screw fixation | Radiographic / clinical | 24 mo | 100 % (nonsmokers) | 94.1 % (nonsmokers) | All scores (ODI, SF-36, back pain, leg pain) improved in all groups at all intervals. Improvements were greater for nonsmokers than smokers. |
| 95.2 % (smokers) | 76.2 % (smokers) | |||||||
| Dimar et al. (2009) | Prospective randomized | 410 | Single level PLIF with pedicle screw fixation | Radiographic / clinical | 24 mo | 96.00 % | 89 % (autograft) | ODI, SF-36, back pain and leg pain showed similar improvements for both groups at all intervals. |
| Dawson et al. (2009) | Prospective randomized | 46 | Single level PLIF with pedicle screw fixation | Radiographic / clinical | 24 mo | 95.00 % | 70 % (autograft) | Significant improvements in both groups. “Trend toward greater improvements” in the investigational group. |
| Boden et al. (2002) | Prospective randomized | 25 | PLIF with or without pedicle screw fixation | Radiographic / clinical | 24 mo | 100 % (with or without pedicle screws) | 40 % (autograft/ pedicle screw) | Statistically significant improvements in ODI score with rhBMP-2 alone seen at 6 wk. RhBMP-2/pedicle screw at 3 mo and control group at 6 mo Improvements in all groups maintained through follow-up. |
| Glassman et al. (2008) | Prospective randomized | 106 | PLIF with pedicle screw fixation | Radiographic / clinical | 24 mo | 86.30 % | 70.8 % (autograft) | Improvements in ODI, SF-36 back pain and leg pain scores at all intervals. No statistical significance. |
| Geibel et al. (2009) | Retrospective | 48 | PLIF | Radiographic / clinical | 17 mo (average) | 100 % | NR | No rhBMP-2 associated complications. |
| High patient satisfaction scores. | ||||||||
| Mulconrey et al. (2008) | Prospective randomized noncontrolled | 98 | ALIF, PLIF with pedicle screw fixation | Radiographic | 24 mo | 95 % (assuming all applications) | NR | NR |
| Maeda et al. (2009) | Retrospective | 55 | ALIF, PLIF with or without pedicle screw fixation | Radiographic / clinical | 24 mo | 95.70 % | 71.9 % (autograft) | NR |
| Hurlbert et al. (2013) | Prospective randomized | 197 | Posterior lumbar with pedicle screw fixation | Radiographic / clinical | 24–48 mo | 96 % (6 mo) | 43 % (6 mo) | Excellent improvements in all clinical scoring criteria post operatively. No statistical difference between investigational and control group. |
| 98 % (12 mo) | 57 % (12 mo) | |||||||
| 97 % (24 mo) | 70 % (24 mo) | |||||||
| 94 % (48 mo) | 69 % (48 mo) | |||||||
| Rihn et al. (2009) | Retrospective | 48 | TLIF | Radiographic / clinical | 19.4 (radiographic) | 95.80 % | NR | Odoms: 71 % good to excellent results. |
| 27.4 (clinical) | Patient satisfaction: 84 % somewhat to very satisfied. | |||||||
| 84 % very likely to undergo procedure again for similar symptoms | ||||||||
| Crandall et al. (2013) | Retrospective | 509 | TLIF | Radiographic / clinical | 59 mo (average) | 98.40 % | NR | Significant improvements in all scores observed at least 24 mo post operatively. |
| Kim et al. (2013) | Cohort | 63 | ALIF, PLIF, (Thoracic to Sacrum) | Radiographic / clinical | 4–14 y | 93.50 % | 71.9 % (autograft) | No statistical difference in ODI scores between the groups. Only the self- image score demonstrated statistically significant differences. |
| Hamilton et al. (2011) | Retrospective | 53 | Posterior cervical | Radiographic / clinical | 24 mo | 100 % | NR | NR |
| 94 % bilateral | ||||||||
| Hodges et al. (2012) | Retrospective | 29 | Posterior cervical | Radiographic / clinical | >12 mo | 89.00 % | NR | No adverse events related to BMP reported. |