Complications with recombinant human bone morphogenic protein-2 in posterolateral spine fusion: a consecutive series of 1037 cases.
ABSTRACT Retrospective case series.
The purpose of this study was to report on a large consecutive series of posterolateral fusion cases using rhBMP-2/ACS.
Despite evidence that rhBMP-2/ACS is effective as an iliac crest graft substitute in posterolateral fusion, concerns remain regarding potential risk for BMP use in clinical practice. These concerns have been fueled by the serious complications reported with BMP in anterior cervical spine fusion. While none of the literature on posterolateral fusion with rhBMP-2/ACS has suggested an increased complication rate versus iliac crest bone graft, this issue has not been specifically studied.
We reviewed medical records for a consecutive series of 1037 patients who underwent posterolateral spine fusion using rhBMP-2 between 2003 and 2006. Medical complications were attributed to the surgical procedure if they occurred within the 3-month perioperative period, whereas complications potentially related to BMP were included regardless of time frame.
Medical and surgical complications were observed in 190 of 1037 patients (18.3%) with 81 major complications (7.8%) and 110 minor complications (10.2%). Neurologic complications were related to screw malposition in 6 patients and epidural hematoma in 3 patients. New or more severe postoperative radicular symptoms were noted in 7 patients (0.7%). Psoas hematoma was identified by CT scan in 8 patients (0.8%). Complications directly related to rhBMP-2 were observed in at least 1 patient (0.1%) and in a worst case analysis, in as many as 6 patients (0.6%).
This study in 1037 patients confirms the relative safety of rhBMP-2/ACS for posterolateral spine fusion. There were extremely few complications directly attributed to rhBMP-2/ACS, and the overall complication rates were consistent with established norms. The stark contrast between this experience and the markedly elevated complication rate reported with anterior cervical BMP usage emphasizes the need to evaluate risks and benefits of bioactive technologies in a site-specific and procedure-specific manner.
- [Show abstract] [Hide abstract]
ABSTRACT: Recent studies generated antithetic results regarding the safety of bone morphogenetic protein-2 (BMP-2) utilization in spine surgery and the effect of this biologic adjunct on myeloma cells remains to be fully elucidated. To present a case of multiple myeloma (MM) exacerbation after BMP-2 implantation in the setting of Lateral Lumbar Interbody Fusion (LLIF). Case report and literature review. The medical records, laboratory findings, and radiographic imaging studies of an eighty-six year-old female patient with exacerbation of previously undiagnosed MM were reviewed. The patient presented with a 10-year-history of debilitating lower back pain, and bilateral lower extremity claudication. Radiographic studies depicted lumbar scoliosis and lateral spondylolisthesis. Pre-operative serum immunofixation electrophoresis showed a serum IgA kappa paraprotein-peak, however, the patient had never been diagnosed with MM or reported any unexplained fever, night sweats, and weight loss indicative of MM. The patient underwent LLIF from L1-L5 supplemented by BMP-2. On post-operative day#1, the patient was evaluated by the hematology department for paraprotenemia. Serum electrophoresis showed decreased albumin, hypogammaglobulinemia, and suspicious broadening of the complement component in the beta region. Post-operative imaging studies (19 weeks) depicted progression of a previously visible intraosseous lesion, and anterior cortical breakthrough (L5), in addition to a soft tissue mass at the T10 level. Histological examination of iliac crest and T10 vertebral biopsies showed fatty marrow infiltration by plasma cells and plasma cell dyscrasia, proving the diagnosis of MM. The patient expired 10 months after surgery due to complications related to a MRSA infection. Based on the present case, perhaps one should consider that in patients with abnormal electrophoresis results, even in the absence of a prior diagnosis of MM as well as in the absence of symptoms indicative of MM, BMPs should only be administered after pre-operative exclusion of neoplastic disease.The spine journal: official journal of the North American Spine Society 10/2013; · 2.90 Impact Factor
- [Show abstract] [Hide abstract]
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; · 2.45 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: To evaluate radiologic result of anterior cervical discectomy and fusion with allobone graft and plate augmentation, and the change of radiologic outcome between screw type and insertion angle. Retrospective review of clinical and radiological data of 29 patients. Segmental angle, height and screw angles were measured and followed. The fusion rate was assessed by plain radiography and CT scans. We divided the patients into two groups according to screw type and angles. Group A: fixed screw, Group B: variable screw. Interscrew angle was measured between most upper and lower screws with Cobb's methods. Overall fusion rate was 86.2% on plain radiography. Fusion was also assessed by CT scan and Bridwell's grading system. There was no difference in fusion and subsidence rates between two groups. Subsidence was found in 5 patients (17.2%). Segmental lordotic angle was increased from preoperative status and maximized at the immediate postoperative period and then reduced at 1 year follow up. Segmental height showed similar increase and decrease values. ACDF with allograft and plate showed favorable fusion rates, and the screw type and angle did not affect results of surgery.Korean Journal of Spine. 09/2013; 10(3):160-4.