Off-label usage of RhBMP-2 in posterior cervical fusion is not associated with early increased complication rate and has similar clinical outcomes

Abstract

BACKGROUND CONTEXTArthrodesis is important for the success of posterior cervical fusion (PCF), however, there exists limited data regarding the safety and efficacy of bone morphogenic protein (BMP) in PCF. PURPOSEThe primary objective was to evaluate early postoperative complications associated with BMP in PCF and determine whether BMP leads to adverse early clinical outcomes. A secondary objective was to determine the optimal location for BMP sponge placement, within the facet joint (IF) or elsewhere, and the optimal dosage/level. DESIGNRetrospective, consecutive case-control study. PATIENT SAMPLESeven hundred sixty-five patients who underwent PCF OUTCOME MEASURESPatient-reported outcomes (PROs), complications, arthrodesis, optimum dose/level of BMP METHODSSurgical data, including preoperative diagnosis, levels fused, type of bone graft, BMP dose (when used), and fusion technique were recorded. Complications were assessed by reviewing the medical record encompassing the first 6-weeks postoperative. These included medical, neurological, and wound-related complications and reoperation. Neurological complications were defined as any new weakness, radicular pain, or numbness. PROs were collected, including SF36, VAS, EQ-5D, and NDI scores. To determine the optimal dosage and location for BMP placement, a sub-analysis was performed. RESULTSThere were no significant differences between the BMP and no BMP group with regards to wound complications, neurological complications, or reoperation. There were no differences in PROs between BMP and no BMP. Placement of BMP for IF and at a dose of 0.87 mg/level minimized wound-related complications. The BMP group had a higher fusion rate compared to the no BMP group (96% vs. 91%, p=.02) when assessed 1 year post-operatively. CONCLUSIONBMP was not associated with a higher rate of early complications after PCF when the dose was minimized. Complications thought to be associated with BMP, such as compressive seroma, radiculitis, and wound-related complications were not seen at a higher rate. PROs at early follow-up were similar. Placement of BMP for IF and at lower doses than previously reported may minimize complications.