• Kern Singh, Sreeharsha V Nandyala, Alejandro Marquez-Lara, Thomas D Cha, Safdar N Khan, Steven J Fineberg, and Miguel A Pelton.
• Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St, Suite 400, Chicago, IL, USA. Electronic address: kernsingh@hotmail.com.
• Spine J. 2013 Sep 1;13(9):1118-25.

Background ContextRecent reports of postoperative radiculitis, bone osteolysis, and symptomatic ectopic bone formation after recombinant human bone morphogenetic protein-2 (rhBMP-2) use in transforaminal lumbar interbody fusions (TLIFs) are a cause for concern.PurposeTo determine the clinical and radiographic complications associated with BMP utilization in a minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) environment.Study Design/SettingRetrospective clinical case series at a single institution.Patient SampleFive hundred seventy-three consecutive patients undergoing an MIS-TLIF.Outcome MeasuresReoperation rates and total costs associated with complications of rhBMP-2 use and pseudarthrosis.MethodsA retrospective review of 610 consecutive patients undergoing an MIS-TLIF (2007-2010) by a single surgeon at our institution was performed (mean age 48.7 years, range 26-82 years). All patients underwent an MIS laminectomy with bilateral facetectomy, single TLIF cage, unilateral pedicle screw fixation, and 12 mg (large kit) or 4.2 mg (small kit) of rhBMP-2. The BMP-2 collagen-soaked sponge was placed anteriorly in the disc space, followed by local bone graft, and then the cage was filled only with local bone and no BMP-2. Patients were evaluated at 6 months and 1 year with computed tomography (CT) scan. Those demonstrating neuroforaminal bone growth, osteolysis/cage migration, or pseudarthrosis were reviewed, and cost data including direct cost/procedure for both index and revision surgeries were collected.ResultsOf the 573 patients, 10 (1.7%) underwent 15 additional procedures based on recalcitrant radiculopathy and CT evidence of neuroforaminal bone growth, vertebral body osteolysis, and/or cage migration. Thirty-nine patients (6.8%) underwent reoperation for clinically symptomatic pseudarthrosis. Bone overgrowth was associated with nerve impingement and radiculopathy in all 10 patients (small kit, n=9; large kit, n=1). Osteolysis and cage migration occurred in 2 (20%) of these same 10 patients. Average total costs were calculated per procedure ($19,224), and the costs for reoperation equaled $14,785 per encounter for neuroforaminal bone growth and $20,267 for pseudarthrosis.ConclusionsSymptomatic ectopic bone formation, vertebral osteolysis, and pseudarthrosis are recognized complications with the use of rhBMP-2 in MIS-TLIFs. Potential causes include improper dosage and a closed space that prevents the egress of the postoperative BMP-2 fluid collection. Management of these complications has a substantial cost for the patient and the surgeon and needs to be considered with the off-label use of rhBMP-2.Copyright © 2013 Elsevier Inc. All rights reserved.

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