Postoperative Complications Associated With rhBMP2 Use in Posterior/Posterolateral Lumbar Fusion

Abstract

Study Design:Retrospective database review.Objective:Posterior/posterolateral lumbar fusion (PLF) is an effective treatment for a variety of spinal disorders; however, variations in surgical technique have different complication profiles. The aim of our study was to quantify the frequency of various complications in patients undergoing PLF with and without human recombinant bone morphogenetic protein 2 (rhBMP2).Methods:We queried the orthopedic subset of the Medicare database (PearlDiver) between 2005 and 2011 for patients undergoing PLF procedures with and without rhBMP2. Complication and reoperation rates were analyzed within 1 year of the index procedure. Complications assessed include: acute renal failure, deep vein thrombosis, dural tear, hematoma, heterotopic ossification, incision and drainage, cardiac complications, nervous system complications, osteolysis, pneumonia, pseudarthrosis, pulmonary embolism, radiculopathy, respiratory complications, sepsis, urinary retention, urinary tract infection, mechanical, and wound complications. Chi-square analysis was used to calculate the complication differences between the groups.Results:Our data revealed higher overall complication rates in patients undergoing PLF with rhBMP2 versus no_rhBMP2 (76.9% vs 68.8%, P < .05). Stratified by gender, rhBMP2 males had higher rates of mechanical complications, pseudarthrosis, and reoperations compared with no_rhBMP2 males (P < .05), whereas rhBMP2 females had higher rates of pseudarthrosis, urinary tract infection, and urinary retention compared with no_rhBMP2 females (P < .05).Conclusion:Our data revealed higher overall complication rates in PLF patients given rhBMP2 compared with no_rhBMP2. Furthermore, our data suggests that rhBMP2-associated complications may be gender specific.

Complications and Revision Rates in Minimally Invasive Robotic-Guided Versus Fluoroscopic-Guided Spinal Fusions

“…The overall event rates of complications and revisions reported in our study are consistent with previous reports on Mazor Core technology 8–10,15,24–28 as well as on FG surgeries 29–31 . The 5.8-fold reduction in complication rates and 11.0-fold reduction in revision rates during the first year after surgery are significant both statistically and clinically.…”

“…The overall event rates of complications and revisions reported in our study are consistent with previous reports on Mazor Core technology [8][9][10]15,[24][25][26][27][28] as well as on FG surgeries. [29][30][31] The 5.8-fold reduction in complication rates and 11.0-fold reduction in revision rates during the first year after surgery are significant both statistically and clinically. The reduced complication and revision rates with Mazor have led the investigator who initially randomized patients to discontinue randomization and continue to enroll.…”

Bone morphogenetic protein-2 induced posterolateral lumbar fusion in a mouse model

“…Since its approval by the United States Food and Drug Administration (FDA) for clinical use, recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely used in the clinical practice of orthopaedic, including a substantial number of "off label" applications 1; 2 . In addition to the approved anterior lumbar interbody fusion, rhBMP-2 is used extensively in other lumbar spinal fusion techniques and at doses that seem to exceed the physiological need 3 . Safety issues pertaining rhBMP-2 have been of concern since the inception of its clinical use.…”

AOSpine Knowledge Forums: Research in Motion

“…With the aforementioned framework in place, since 2011 the AOSpine Knowledge Forums have published over 139 peer-reviewed articles in numerous esteemed journals such as Cancer , 1 Neuro-Oncology , 2 Journal of Bone and Joint Surgery , 3 Spine , 4,5 European Spine Journal , 6 and the Global Spine Journal , 7-10 among others. The AOSpine Knowledge Forums have amassed over 20 international awards and accolades related to their research, such as the Russel A. Hibbs Award, the Whitecloud Award, various Young Investigator Awards, and other Best Clinical Presentation Awards at various conferences.…”

“…Through this research and collaboration, the Forums have gone on to develop guidelines for the diagnosis and treatment of various spinal disorders, outcome instruments, cost-analyses/cost-effectiveness, novel classification schemes, predictive modelling, and treatment recommendations. 2-25 As a knowledge “mobilizer,”they have sought to raise awareness of their findings via knowledge exchange and dissemination, have fostered research education and mentorship, and strived to translate their findings to ultimately improve patient care and quality of life on the international stage.…”