Maintenance of Segmental Lordosis and Disk Height in Stand-alone and Instrumented Extreme Lateral Interbody Fusion (XLIF) :

Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight. To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases. Systematic review. Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses. There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2-associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate <0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy. Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications. Copyright © 2011 Elsevier Inc. All rights reserved. Show more

Sensitivity and specificity of lumbar spine radiography in the assessment of facet joint osteoarthritis were evaluated, with computed tomography (CT) as the standard. Two independent radiologists used a four-point scale to blindly grade facet joint osteoarthritis on oblique radiographs and transaxial CT scans obtained within an 8-month period in 50 consecutive patients with pain in the lower back. The L-3 to L-4, L-4 to L-5, and L-5 to S-1 facet joints were evaluated, and 68% appeared abnormal on CT scans, with 28% exhibiting moderate or severe disease. Interobserver agreement was high for conventional radiography (perfect agreement in 57% and agreement to within one grade in 39%) and still higher for CT (perfect in 63% and to within one grade in 35%). Receiver operating characteristic curve analysis indicated that oblique radiography was most accurate (55% sensitivity, 69% specificity) in distinguishing the presence from the absence of disease; in distinguishing absent or mild from moderate or severe disease, the specificity of oblique radiography was higher, at 94%, but its sensitivity was much lower, at 23%. Conventional radiography is a useful technique in screening for facet joint osteoarthritis but is insensitive compared with CT. Show more

A biomechanical investigation using indentation tests in a human cadaveric model to seek variation in the structural properties across the lower lumbar and sacral endplates. To determine 1) if there are regional differences in endplate strength and 2) whether any differences identified are affected by spinal level (lumbar spine vs. sacrum) or endplate (superior vs. inferior). It has been postulated that some regions of the vertebral body may be stronger than others. Conclusive data, either supporting or disproving this theory, would be valuable for both spine surgeons and implant designers because one mode of failure of interbody implants is subsidence into one or both adjacent vertebrae. Indentation tests were performed at 27 standardized test sites in 62 bony endplates of intact human vertebrae (L3-S1) using a 3-mm-diameter, hemispherical indenter with a test rate of 0.2 mm/sec to a depth of 3 mm. The failure load and stiffness at each test site were determined using the load-displacement curves. Three-way analyses of variance were used to analyze the resulting data. Both the failure load and stiffness varied significantly across the endplate surfaces (P < 0.0001), with posterolateral regions being stronger and stiffer than the central regions. Characteristic distributions were identified in the lumbar superior, lumbar inferior, and sacral endplates. The failure load distributions were found to differ in 1) the superior lumbar and sacral endplates (P = 0.0077), 2) the inferior lumbar and sacral endplates (P = 0.0014), and 3) the superior and inferior lumbar endplates (P < 0.0001). The sacral and inferior lumbar endplates were both found to be stronger than the superior lumbar endplates (sacrum, P = 0.054; inferior, P = 0.008) but were not themselves significantly different (P = 0.89). Highly significant regional strength and stiffness variations were identified in the lumbar and sacral endplates. The center of the bone, where implants are currently placed, is the weakest part of the lumbar endplates and is not the strongest region of the sacral endplate. Show more