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 followup) 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.
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robustness and effectiveness. This framework was used to assess a series of safety-related incidents in our clinic related to one selected, relatively common, challenge in our clinic. Results: Final care path included 160 steps. Twelve incidents (involving 0.3% of patients) occurring during a defined time related to patient site setup notes, that could have led to site setup errors ("top event"), were analyzed in depth. Human errors contributing to these incidents were then labeled as threats to site setup fidelity. Five incidents were related to the threat of conflicting bladder information (bladder full vs. empty), 3 related to iso-center shift differences between documentation in the site setup note compared to elsewhere, 3 related to missing a site setup note entirely, and 1 related to the site setup note not followed at patient setup. Table presents a representative example of controls and their type including their effectiveness to prevent these threats. Conclusion: BTA provided valuable insight into the identity and efficiency of the controls within our department to protect against errors related to a representative "top event" (e.g. site setup errors). This analysis has helped us realize that we need to improve the robustness and effectiveness of many of our controls and strategically implement audits into our QA management program to help ensure patient safety.
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