Butterman GR. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion
Midwest Spine Institute Stillwater, Spine Surgery Division, 1950 Curve Crest Blvd, Stillwater, MN 55115, USA. The Spine Journal
(Impact Factor: 2.43).
05/2008; 8(3):426-35. DOI: 10.1016/j.spinee.2006.12.006
Anterior cervical discectomy and fusion (ACDF) using autogenous iliac bone graft may lead to donor-site morbidity. This has led some surgeons to use alternatives to iliac bone graft, but often the alternatives have greater rates of nonunion and delayed union. Bone morphogenic protein (BMP) studies have found high arthrodesis rates in lumbar fusions.
The objective of this pilot study was to compare the success of BMP combined with bone allograft with iliac bone autograft in ACDF patients.
The institutional review board approved a prospective but nonrandomized study of 66 consecutive patients who had primary one- to three-level ACDF with either iliac-crest bone autograft or BMP allograft (0.9 mg BMP per level) followed prospectively over a 2- to 3-year period.
Consecutive patients who had primary one- to three-level ACDF with either iliac-crest bone autograft (n=36) or BMP-allograft (n=30). Patients in both iliac bone graft and BMP-allograft groups had comparable preoperative pain and disability.
Visual analog scale pain, pain drawing, Oswestry index, pain medication use, opinion of treatment success, and neurological recovery.
Given the nonrandomized nature of the study, the study groups were not matched. Within this limitation, both groups of patients had similar improvement in all outcome scales (visual analog scale pain, pain drawing, Oswestry index, pain medication use, and opinion of treatment success) and neurological recovery over the 2- to 3-year follow-up period. Patients in the iliac bone graft group had two pseudarthroses and two complications of the iliac-crest donor site. In the BMP-allograft group, one patient had a pseudarthrosis, but 50% had neck swelling presenting as dysphagia, which was substantially more common than the 14% present in the iliac bone graft group. Patients in the BMP-allograft group had slightly shorter surgery time, but implant and hospitalization costs were higher.
ACDF performed with BMP (0.9 mg BMP per level) allograft is as effective as iliac bone graft in terms of patient outcomes and fusion rates. Safety concerns related to neck swelling and higher initial costs were associated with patients in the bone morphogenic protein group.
Available from: Brook I. Martin
- "The figure is annotated by the publication dates of studies by Shields et al. , Pradhan , Lewandrowski et al. , Vaidya et al. , and Buttermann , which were among the first case series to report wound complication, osteolysis, and dysphagia with BMP in anterior cervical fusion. Those by Mindea et al. , Wong et al. , Joseph and Rampersaud , and Carragee et al.  were the first to raise concerns about postoperative radiculitis and retrograde ejaculation with lumbar fusions involving BMP. "
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ABSTRACT: Use of Bone Morphogenetic Protein (BMP) as an adjunct to spinal fusion surgery proliferated following Food and Drug Administration (FDA) approval in 2002. Major safety concerns emerged in 2008.
To examine whether published concerns about the safety of BMP altered clinical practice.
Analysis of the National Inpatient Sample from 2002 through 2012.
Adults (age >20) undergoing an elective fusion operation for common degenerative diagnoses, identified using codes from the International Classification of Diseases, 9(th)revisions, Clinical Modification (ICD-9-CM).
Proportion of cervical and lumbar fusion operations, over time, that involved BMP.
We aggregated the data into a monthly time series and reported the proportion of cervical and lumbar fusion operations, over time, that involved BMP. Auto Regressive Integrated Moving Average, a regression model for time series data, was used to test whether there was a statistically significant change in the overall rate of BMP use following a FDA Public Health Notification in 2008. The study was funded by federal research grants, and no investigator had any conflict of interests.
Use of BMP in spinal fusion procedures increased rapidly until 2008, involving up to 45.2% of lumbar and 13.5% of cervical fusions. BMP use significantly decreased following the 2008 FDA Public Health Notification and revelations of financial payments to surgeons involved in the pivotal FDA approval trials. For lumbar fusion, the average annual increase was 7.9 percentage points per year from 2002 to 2008, followed by an average annual decrease of 11.7 percentage points thereafter (p = <0.001). Use of BMP in cervical fusion increased 2.0% per year until the FDA Notification, followed by a 2.8% per year decrease (p = 0.035).
Use of BMP in spinal fusion surgery declined subsequent to published safety concerns and revelations of financial conflicts-of-interest for investigators involved in the pivotal clinical trials.
Copyright © 2014 Elsevier Inc. All rights reserved.
- "Cahill et al. reported that the national rate of BMP application increased from less than 1% of all fusions in 2002 to close to 25% of all fusions in 2006. As BMP use has been associated with increases of 11%–41% in total hospital charges, as well as longer lengths of hospitalization for patients,[36–815–1621242631] it is imperative to fully understand the risks and benefits of BMP. "
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ABSTRACT: Many studies offer excellent demonstration of the ability of bone morphogenic protein (BMP) to enhance fusion rates in anterior as well as posterior lumbar surgery. Recently, BMP has also been shown to increase arthrodesis rates in anterior cervical surgery, albeit with concomitant increases in complication rates. To date, however, few studies have investigated the safety and efficacy of BMP in cervical surgeries approached posteriorly.
We retrospectively reviewed 204 consecutive patients with degenerative cervical spinal conditions necessitating posterior cervical fusion at a single institution over the past 4 years. The incidence of postoperative mechanical neck pain, fusion rates, as well as neurologic outcomes were compared between patients who received BMP vs those who did not receive BMP intraoperatively.
There were no significant differences in preoperative variables between the non-BMP vs the BMP cohorts. Over an average follow-up of 24.2 months, there were no significant differences between the two cohorts in duration of hospitalization, cerebrospinal fluid leakage, deep vein thrombosis, pulmonary embolism, hyperostosis, infection, pneumonia, hematoma, C5 palsy, wound dehiscence, reoperation rates, or Nurick/ASIA scores. Eleven (7.1%) patients in the non-BMP group experienced instrumentation failure vs none in the BMP group (P=0.06). Patients receiving BMP had a significantly increased rate of fusion by the chi-square test (P=0.01) and the log-rank test (P=0.02). However, patients receiving BMP also had the highest rates of recurrent/persistent neck pain by the chi-square test (P=0.003) and the log-rank test (P=0.01).
To date, few studies have evaluated the safety and efficacy of BMP in the posterior cervical spine. Here, we show that BMP usage does not increase complication rates, but it significantly increases arthrodesis rates and also may increase the rate of recurrent/persistent neck pain.
- "In a third 1-ACDF study utilizing cage/mesh/autograft cancellous bone/plate (27 patients) versus iliac autograft spacer/plate (27 patients), operative costs proved comparable; the operative time saved by avoiding iliac crest bone harvesting was negated by the increased cost of the cage. Two other studies documented that utilizing BMP/INFUSE as a bone graft supplement for 1-ACDF spacers was not cost-effective, as it markedly exacerbated postoperative dysphagia, prolonged the LOS, and increased operative costs. "
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ABSTRACT: Few studies focus on the fusion rates and outcomes for single-level anterior cervical diskectomy/fusion (1-ACDF) utilizing iliac autograft and dynamic plates.
Fusion rates and outcomes were prospectively evaluated in 60 consecutive patients undergoing 1-ACDF utilizing iliac autograft and dynamic plates (ABC; Aesculap, Tuttlingen, Germany). Eighteen patients had radiculopathy, while 42 were myelopathic (average Nurick Score 3.3). Pathology included single-level disc disease/spondylosis (38 patients) and/or ossification of the posterior longitudinal ligament (OPLL, 22 patients). Fusion was assessed at 3, 6, and up to 12 months postoperatively utilizing dynamic X-rays and 2D-CT scans. Outcomes were evaluated up to 24 months postoperatively utilizing Odom's Criteria, Nurick Grades, and Short-Form 36 (SF-36) outcome questionnaires. Patients were followed for an average of 4.8 postoperative years (minimum 2 years).
Although dynamic X-rays/2D-CT studies documented 100% fusion an average of 3.8 months (range 2.5-8 months] postoperatively, 5 heavy smokers exhibited delayed fusions [6-8 months postoperatively]. Two years postoperatively, the average Nurick Score was 0.3 (mild radiculopathy), while Odom's Criteria revealed 52 excellent, 6 good, and 2 fair outcomes [the latter 8 patients were heavy smokers]). Utilizing SF-36 outcome questionnaires, patients markedly improved (>10.0 point gain) on 5 of 8 Health Scales within 6 months, 7 of 8 within 1 year, and all 8 within 2 postoperative years.
For 60 patients undergoing 1-ACDF utilizing dynamic plates, ultimately a 100% fusion rate was achieved (5 heavy smokers exhibited delayed fusions). Two years postoperatively, Nurick Grades, Odom's Criteria, and SF-36 questionnaires revealed adequate outcomes.
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