Multilevel anterior cervical discectomy and fusion with and without rhBMP-2: a comparison of dysphagia rates and outcomes in 150 patients.
ABSTRACT Object Reported complications of recombinant human bone morphogenetic protein-2 (rhBMP-2) use in anterior cervical discectomy and fusion (ACDF) cases include dysphagia and cervical swelling. However, dysphagia often occurs after multilevel ACDF procedures performed with allograft (without BMP) as well. To date, there has been no large study comparing the dysphagia rates of patients who have undergone multilevel ACDF using allograft spacers with those who underwent ACDF using polyetheretherketone (PEEK) cages filled with rhBMP2. The authors report one of the first such comparisons between these 2 patient cohorts. Methods The authors retrospectively reviewed 150 patient records. Group 1 (BMP group) consisted of 100 patients who underwent multilevel ACDF with PEEK cages filled with rhBMP-2 and instrumented with a cervical plate. Group 2 (allograft group) included a matched control cohort of 50 patients who underwent multilevel ACDF with allograft spacers and anterior plate fixation (without rhBMP-2). Patient demographics were not significantly different between the groups. Fusion was assessed by means of dynamic radiographs and/or CT at routine intervals. Complications, dysphagia incidence, standardized dysphagia score, Nurick grades, and fusion rates were assessed. Results The mean follow-up for the BMP group (Group 1) was 35 months while the mean follow-up for the allograft group (Group 2) was 25 months. There was a complication rate of 13% in the BMP group compared with 8% in the allograft group (p < 0.005). There was no significant difference in overall dysphagia incidence between the BMP group and the allograft group (40% vs 44%, respectively; p > 0.05). However, there was a significant difference in the severity of dysphagia (using the SWAL-QOL dysphagia scoring system) between the 2 groups: 0.757 for the BMP group versus 0.596 for the allograft group (p < 0.005). In subgroup analysis, the use of rhBMP-2 significantly increased the severity of dysphagia in patients undergoing 2-level ACDF (p < 0.005). However, the severity of dysphagia did not differ significantly between groups when 3- or 4-level ACDF cases were compared. There was no pseudarthrosis in Group 1 (the BMP group) compared with a 16% pseudarthrosis rate in Group 2 (the allograft group) (p < 0.05). There was a weak correlation between the total rhBMP-2 dose and the dysphagia score (Kendall tau rank correlation coefficient 0.166, p = 0.046). Conclusions The use of rhBMP-2 in patients undergoing 2-level ACDF significantly increases the severity of dysphagia (dysphagia score) without affecting the overall incidence of dysphagia. However, there is no statistically significant difference in the incidence or severity of dysphagia between patients undergoing 3-level or 4-level ACDF treated with PEEK/rhBMP-2 and those treated with only allograft. The use of rhBMP-2 appears to reduce the risk of pseudarthrosis. This benefit is most pronounced in patients who undergo 4-level ACDF and are smokers.
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ABSTRACT: This study was conducted with 2 purposes. The first was to determine the effect of a single dose of zoledronic acid (ZA) on the healing of a tooth extraction socket in dogs. The second was to determine if placement of recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS) - INFUSE, (Medtronic, Memphis, TN) into these extraction sockets would inhibit the inhibition on bone healing and remodeling by ZA. Nine adult female beagle dogs (2 to 3 yr old) were placed into 3 groups of 3 dogs each. Group I received 15 mL of sterile saline intravenously; group II received 2.5 mg of ZA intravenously; and group III received 5 mg of ZA intravenously. Forty-five days after treatment, all dogs underwent extraction of noncontiguous right and left mandibular first molars and second premolars. In group I, the right mandibular extraction sockets had nothing placed in them, whereas the left mandibular sockets had only ACS placed in them. In groups II and III, the right mandibular sockets had rhBMP-2/ACS placed in them, whereas the left mandibular sockets had only ACS placed. All extraction sockets were surgically closed. Tetracycline was given intravenously 5 and 12 days later, and all animals were euthanized 15 days after tooth extraction. The extraction sockets and rib and femur samples were harvested immediately after euthanasia, processed, and studied microscopically. A single dose of ZA significantly inhibited healing and bone remodeling in the area of the tooth extractions. The combination of rhBMP-2/ACS appeared to over-ride some of the bone remodeling inhibition of the ZA and increased bone fill in the extraction sites, and remodeling activity in the area was noted. The effects of rhBMP-2/ACS were confined to the area of the extraction sockets because bone activity at distant sites was not influenced. A single dose of ZA administered intravenously inhibits early healing of tooth extraction sockets and bone remodeling in this animal model. The combination of rhBMP-2/ACS significantly increased bone fill and bone remodeling in these areas, negating much of the effect of the ZA.Journal of oral and maxillofacial surgery: official journal of the American Association of Oral and Maxillofacial Surgeons 07/2013; 72(1). DOI:10.1016/j.joms.2013.06.192
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ABSTRACT: Study Design. Systematic ReviewObjective. A systematic review was performed to identify the types of complications and complication rates associated with the use of bone morphogenetic protein (BMP) in both anterior and posterior cervical and lumbar spine surgery.Summary of Background Data. There has been an increase in BMP use in various clinical situations typically in an "off-label" fashion. Associated with its use, however, have been reports of various complications.Methods. A MEDLINE search was conducted. All articles involving complications following spine surgery in patients receiving BMP were included. Articles were excluded based upon the following criteria: Non-English manuscripts and non-human subjects. A total of 29 articles met the inclusion and exclusion criteria and were used in the analysis. For each complication identified, the incidence was calculated by pooling the subjects from the studies that reported the complication. Chi-square tests were used to compare the incidence rates between those that had received BMP and the control groups.Results. Of the 29 articles included, 7 reported complication rates in anterior cervical fusions, 3 in posterior cervical fusions, 4 in anterior lumbar interbody fusions (ALIF), 9 in posterior/transforaminal lumbar interbody fusions (PLIF/TLIF), and 6 in posterolateral lumbar fusions. Individual complication rates when BMP was used ranged from 0.66-20.1% in anterior cervical fusions, 3.5-14.6% in posterior cervical fusions, 2.0-7.3% in ALIFs, 1.5-21.8% in PLIF/TLIFs, and 1.4-8.2% in posterolateral lumbar fusions. Pseudarthrosis rates were statistically significantly lower with the utilization of BMP in all procedures except for PLIF/TLIFs, which only approached significance (p = 0.07). The only individual complication that was statistically significantly greater with BMP utilization was retrograde ejaculation in ALIFs (7.3 vs. 2.3%; p = 0.03). The rate of dysphagia/swelling in anterior cervical fusions was greater with BMP (20.1 vs. 15.6%), however this only approached statistical significance (p = 0.07).Conclusion. The body of literature reports complication rates with BMP ranging from 0.66%-21.8%. However, the only statistically significant adverse complication rate was retrograde ejaculation in the ALIF population (7.3%). Despite the increased awareness of complications associated with BMP, complication rates remain spine site specific and low. Thorough patient education should be done with the physician to make an informative use regarding BMP utilization in spinal surgery.Spine 09/2013; 39(1). DOI:10.1097/BRS.0000000000000004
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ABSTRACT: Although anterior cervical discectomy and fusion (ACDF) is a safe and effective procedure, the complications associated with it cannot be underestimated. The aim of this study was to highlight the potential complications associated with ACDF and the strategies to avoid them. A total of 1576 patients was included in this retrospective study from 1995 to 2012. All patients were operated by a single surgeon using the standard technique. Data pertaining to the postoperative complications and mortality was collected from the database. The overall ACDF related complication in our series was 8.4 % (n=133). Dysphagia was the most common complication encountered in 3.3 % (n=52) of our patients. The inadvertent dural tear was encountered in 1.3% (n=20) of our patients. Hoarseness was seen in 1.2% (n= 19) of our patients. 0.88% (n=14) of the patients had worsening of myelopathy/radiculopathy in the immediate postoperative period. Superficial wound infection occurred in 0.2% (n=3) of our cases. Postoperative neck hematoma was seen in 0.1 % (n=2), recurrent laryngeal nerve palsy in 0.1 % (n=2), esophageal tear in 0.1% (n=1) and graft extrusion in 0.88% (n=14) of our cases. There was 0.1% (n=1) mortality in our series. Of all these complications, only dysphagia was significantly correlated with 3 level ACDF as compared to 1 or 2 level ACDF (H = 12.89, df= 3, p = 0.05). ACDF is a relatively safe procedure with very low morbidity and almost no mortality. In this study, the common complications encountered were postoperative dysphagia, dural injury and hoarseness.World Neurosurgery 09/2013; 82(6). DOI:10.1016/j.wneu.2013.09.022