Experience With Recombinant Human Bone Morphogenetic Protein-2 in Posterior Lumbar Interbody Fusion: A Retrospective Review of 1019 Procedures.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) combined with an activated collagen scaffold (Infuse; Medtronic, MN) has been used to facilitate lumbar intervertebral fusion; however, data regarding its efficacy are inconsistent. We aimed to assess the efficacy of rhBMP-2 when used in posterior lumbar interbody fusion (PLIF) by analyzing the rate of reoperation for nonunion and patient-reported outcome measures in a large retrospective case series. We also aimed to assess the impact of patient and surgical factors on rates of reoperation and determine frequency of complications.

METHODS: Prospectively collected data from a single-surgeon database of consecutive PLIFs (minimum 18-month follow-up) were retrospectively analyzed. PLIF was performed with pedicle screw instrumentation, intervertebral spacers, and locally harvested bone graft to which rhBMP-2 and bone marrow aspirate (BMA) were added. Multivariate logistic regression was used to determine the influence of patient and surgical factors on the primary outcome: reoperation for confirmed nonunion.

RESULTS: A total of 1019 operations at 1485 levels across 908 patients were analyzed. Mean duration of follow-up was 51.7 ± 30.0 months (range 18-172). Twelve patients required reoperation for nonunion (1.2%). Increasing body mass index was found to be significant in predicting reoperation (OR 1.114, P = 0.046). Postoperative radiculitis was common (42%) but transient in most cases. There were significant and sustained improvements in patient-reported outcome measures postoperatively. Four cases of osteolysis and 5 of epidural cyst were recorded, and a reduction of rhBMP-2 dose seemed to ameliorate these sequelae.

CONCLUSION: In this large retrospective observational study, PLIF performed with rhBMP-2 and BMA resulted in a low rate of clinically significant nonunion and significant improvement in patient-reported outcomes. Transient radiculitis was common. Osteolysis and epidural cyst formation were rare and possibly related to dosage.

CLINICAL RELEVANCE: rhBMP-2 is effective when used in PLIF, resulting in a high rate of fusion and improved patient outcomes, and it has an acceptable safety profile.