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Abstract: Background context: Bone morphogenetic protein-2 (BMP-2) (Infuse) has been approved for use in anterior lumbar fusion in conjunction with an LT cage. However, off-label use is seen with anterior cervical fusion, posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF). The Federal Food and Drug Administration trial of BMP-2 in a PLIF application was halted because of a high incidence of ectopic bone forming in the neural canal (75%). The authors did not find a correlation between ectopic bone and increased leg pain. They concluded that the ectopic bone was a radiographic phenomenon and not associated with clinical findings. Complications using BMP in the cervical spine have been reported. Heretofore, there has not been a similar warning voiced for use of BMP in a lumbar PLIF or TLIF. Purpose: The purpose was to report five cases of ectopic bone in the canal associated with PLIF/TLIF off-label use of BMP-2 potentially contributing to abnormal neurologic findings. Study design/setting: This is an observational cohort study of patients referred to a tertiary care private medical center. Methods: This was a retrospective chart review of patients referred to a tertiary spine institute with complications after surgery where BMP-2 had been used in an off-label PLIF or TLIF application. Patient demographics, operating room (OR) notes from the index BMP surgery, imaging studies, and current clinical status were reviewed. Results: Five cases of ectopic bone in the spinal canal with potential neurologic compromise were identified. Conclusions: It does appear that ectopic bone in the spinal canal associated with BMP-2 use in PLIF or TLIF may contribute to symptomatic neurologic findings in rare cases. Revision surgeries are difficult. This article challenges a previous publication, which concluded that the high incidence of ectopic bone was of no clinical significance. Isolating BMP anteriorly in the disc space using layered barriers of bone graft between the BMP and the annular defect may reduce the incidence of ectopic bone in the spinal canal. Surgeons need to weigh the benefits versus risks of any technology used off label when making treatment decisions with their patients. [Copyright &y& Elsevier]

Abstract: Background context: The role of total disc arthroplasty (TDA) in the treatment of spinal pathology is unclear. TDA has been touted as an alternative to fusion. However, not all back pain is purely discogenic in origin. Contraindications to TDA exist. At Spine Week in Porto, Portugal, Cammisa''s group from the Hospital for Special Surgery in New York presented a series of 56 fusions where 100% of patients had one or more of 10 contraindications to TDA. En face, this appears to be an extremely large number. Purpose: The purpose of the study was to repeat the Hospital for Special Surgery study in another cohort of fusion patients. Study design/setting: This study was an independent, retrospective record review of 100 consecutive lumbar spinal fusions performed at a tertiary care private medical center. Patient sample: All adult patients having primary1–3 level lumbar spinal fusions from January 2003 to May 2004 were assessed. Outcome measures: Physiologic measures included imaging, range of motion, and response to facet blocks. Methods: A retrospective chart review was performed of 100 consecutive patients having primary 1–3 level lumbar fusion by all five active staff spinal surgeons (3 orthopedic and 2 neurosurgeons). The review was performed independently by the doctorate level physiotherapist who serves as the medical center''s research coordinator, reporting to the chairman of the Hospital institutional review board. The same 10 contraindications from Cammisa''s study were noted. Additional facet arthrosis data were collected, including mention on imaging reports or operating room notes. Clinical notes were reviewed for documentation of range of lumbar motion (ROM) and whether there was restricted or painful extension ROM. Note was made if patients had facet blocks as another clinical indicator of facet arthrosis. Results: All 100 patients had at least one contraindication to TDA. The average was 3.69 (range 1–7). Only one patient had facet arthrosis as their only contraindication. Facet arthrosis was documented on imaging reports or operating room notes in 97/100. Reduced extension was present in 71/75 charts that documented ROM. Facet blocks were performed in 12/100 and gave greater than 50% relief in nine. Conclusions: Both our study and Cammisa''s indicate that all lumbar fusion patients in our two institutions have at least one contraindication to TDA. The average fusion patient does not appear to have isolated discogenic pain. A large proportion of the patients appeared to have facet arthritis. The point where facet arthrosis definitely constitutes a contradiction to TDA will require analysis during long-term arthroplasty follow-up studies. Suitable patients for TDA may not represent a significant cohort presently undergoing lumbar fusion. [Copyright &y& Elsevier]

Commentary on: Kepler CK, Wilkinson SM, Radcliff KE, et al. Cost-utility analysis in spine care: a systematic review. Spine J 2012;12:676–90 (in this issue). [ABSTRACT FROM AUTHOR]

Commentary On: Battié MC, Jones CA, Schopflocher DP, Hu RW. Health-related quality of life and comorbidities associated with lumbar spinal stenosis. Spine J 2012;12:189-95 (in this issue). [ABSTRACT FROM AUTHOR]

COMMENTARY ON: Battié MC, Jones CA, Schopflocher DP, Hu RW. Health-related quality of life and comorbidities associated with lumbar spinal stenosis. Spine J 2012;12:189–95 (in this  issue). [Copyright &y& Elsevier]

Background Context: High quality evidence is difficult to generate, leaving substantial knowledge gaps in the treatment of spinal conditions. Appropriate use criteria (AUC) are a means of determining appropriate recommendations when high quality evidence is lacking.Purpose: Define appropriate use criteria (AUC) of cervical fusion for treatment of degenerative conditions of the cervical spine.Study Design/setting: Appropriate use criteria for cervical fusion were developed using the RAND/UCLA appropriateness methodology. Following development of clinical guidelines and scenario writing, a one-day workshop was held with a multidisciplinary group of 14 raters, all considered thought leaders in their respective fields, to determine final ratings for cervical fusion appropriateness for various clinical situations.Outcome Measures: Final rating for cervical fusion recommendation as either "Appropriate," "Uncertain" or "Rarely Appropriate" based on the median final rating among the raters.Methods: Inclusion criteria for scenarios included patients aged 18 to 80 with degenerative conditions of the cervical spine. Key modifiers were defined and combined to develop a matrix of clinical scenarios. The median score among the raters was used to determine the final rating for each scenario. The final rating was compared between modifier levels. Spearman's rank correlation between each modifier and the final rating was determined. A multivariable ordinal regression model was fit to determine the adjusted odds of an "Appropriate" final rating while adjusting for radiographic diagnosis, number of levels and symptom type. Three decision trees were developed using decision tree classification models and variable importance for each tree was computed.Results: Of the 263 scenarios, 47 (17.9 %) were rated as rarely appropriate, 66 (25%) as uncertain and 150 (57%) were rated as appropriate. Symptom type was the modifier most strongly correlated with the final rating (adjusted ρ2 = 0.58, p<.01). A multivariable ordinal regression adjusting for symptom type, diagnosis, and number of levels and showed high discriminative ability (C statistic = 0.90) and the adjusted odds ratio (aOR) of receiving a final rating of "Appropriate" was highest for myelopathy (aOR, 7.1) and radiculopathy (aOR, 4.8). Three decision tree models showed that symptom type and radiographic diagnosis had the highest variable importance.Conclusions: Appropriate use criteria for cervical fusion in the setting of cervical degenerative disorders were developed. Symptom type was most strongly correlated with final rating. Myelopathy or radiculopathy were most strongly associated with an "Appropriate" rating, while axial pain without stenosis was most associated with "Rarely Appropriate." [ABSTRACT FROM AUTHOR]