Preparation. A rod is used to hold the vertebra together to allow fusion to occur. J Neurosurg Spine. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). An official website of the United States government. 1. Dr. Abd-El-Barr is a consultant for Spineology. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. This study has shown that percutaneous insertion of pedicle screws in the lumbar spine is a safe and reliable technique, and despite the low misplacement rate of only 6.6%, it should be kept in mind that the surgical procedure is technically demanding and should be performed only by experienced spine surgeons. Copyright 2023 Becker's Healthcare. However, published reports are increasingly demonstrative of the positive effect of pedicle fixation on arthrodesis and successful outcome in the treatment of patients with these disorders. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? In six patients (5.3%) with degenerative spine disease, the disc material had been removed. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. The site is secure. Neurosurgical practice liability: relative risk by procedure type. J Neurosurg Spine. pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. were excluded from analysis. A total of 2396 screws were placed accurately (87.96%). Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Nahed BV, Babu MA, Smith TR, Heary RF. Spine 17:834837, 1992. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. NCI CPTC Antibody Characterization Program. 27. You may be trying to access this site from a secured browser on the server. Statistical analysis: Sankey. A.J. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. J Bone Joint Surg 54A:11951204, 1972. The rate of misplaced pedicle screws ranges from 1.1% to 28.8%, 10 although neurologic injury from misdirected pedicle screws has been reported to occur in 0% to 12% of patients. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. However, only a few complications were related to a poor clinical outcome. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). 12. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Privacy Policy. In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Categorical and continuous data are described as frequency (percentage) and median (interquartile range), respectively, except for the use of mean standard deviation for award amounts since both nominal and inflation-adjusted award totals passed (alpha = 0.05) the DAgostino-Pearson omnibus normality test. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 6. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. To reinforce spinal fixation, we have proposed a construct with segmental pedicle fixation two levels above and one level below the injured level and insertion of a screw deep into the pedicle, providing more contact area between screw head and bone and reducing the moment arm of the bending stress. Legal liability in iatrogenic orbital injury. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 9. Intraoperative pedicle fractures requiring further points of fixation. While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. 8600 Rockville Pike The cost of defensive medicine on 3 hospital medicine services. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. Spine J. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. The .gov means its official. Ann Thorac Surg. PMC Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Spine 13:952953, 1988. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. In White AH, Rothman RH, Ray CD (eds). Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Health Aff (Millwood). 2011;365(7):629636. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Thu, May 27th, 2021. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). JAMA. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). Weinstein JN, Spratt KF, Spengler D, Brick C, Reid S: Spinal pedicle fixation: Reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement. Your message has been successfully sent to your colleague. J Neurosurg Spine. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. 2016;25(3):716723. Accuracy of pedicle screw insertion by AIRO intraoperative CT in complex spinal deformity assessed by a new classification based on technical complexity of screw insertion. + 48 696 042 504. Nevertheless, research has shown that screws are misplaced in approximately 14%55% of cases using the standard techniques (freehand and 2D fluoroscopic guidance) employed by most spine surgeons,21,33 resulting in injury in approximately 1%8% of cases.21 In addition to the avoidable procedural risk to the patient, each misplaced screw carries the threat of future litigation, as reported above. Insuring spinal neurosurgery. A p < 0.05 was considered statistically significant. Please try after some time. 2002;27(22):24252430. The https:// ensures that you are connecting to the * Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. . Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Surg Neurol Int. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Eur Spine J. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. 2012;37(1):6776. 2012 Feb 1;37(3):E188-94. Spine 24:23522357, 1999. However, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Orthop Trans 11:99, 1987. 26. Call me tomorrow. 2016;124(5):15241530. 2016;102(2):358362. Balch CM, Oreskovich MR, Dyrbye LN, et al. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 22. Would you like email updates of new search results? In six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). 2019;19(7):12211231. Lawsuit information regarding the plaintiffs age at the time of the malpractice claim, sex, postoperative complaint, indication for index surgery, defendant surgeon specialty (neurosurgery vs orthopedics), and delayed diagnosis or treatment, as well as case location by state and case year, was obtained. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. I won't be at the office but I will check my voice mail. Seven hundred sixty-three screws were inserted in 138 patients. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . A total of 2724 screws were placed in 127 patients. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. Daniels AH, Ruttiman R, Eltorai AEM, et al. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . 2011;306(10):1088. Svider PF, Kovalerchik O, Mauro AC, et al. Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. PLoS One. 24. 1. to maintaining your privacy and will not share your personal information without Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 23. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Dr. Shaffrey has received grants from the NIH and Department of Defense. 3). A total of 69 patients (mean age, 67.416 . To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. The medicolegal landscape of spine surgery: how do surgeons fare? Problems at the junctions of the instrumented spine were seen in five patients (4.5%). In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. Before L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. However, the misplacement of pedicle screws can lead to disastrous complications. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. Spine 18:11601172, 1993. Orthopedics. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Don't jump in get legal help. Show more. 2013;34(6):699705. concluded that the robot-assisted technique was significantly more accurate than the traditional freehand technique.39 Despite the learning curve and initial cost of obtaining technologies such as 3D fluoroscopic devices, intraoperative CT, or robotic navigational systems, the routine use of these technologies for intraoperative imaging confirmation and potential revision of misplaced screws may help spine surgeons avoid inadvertent iatrogenic morbidity for their patients and potential litigation. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 11. 2012;7(6):e39237. your express consent. Rovit RL, Simon AS, Drew J, et al. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). EOS System Courtesy of EOS imaging. One hundred twelve patients were treated using the Cotrel-Dubousset pedicle screw fixation system for degenerative disease (57 patients), trauma (42 patients), infection (eight patients), and tumor (five patients) of the lumbar or thoracolumbar spine. 2013;123(9):20992103. 2011;213(5):657667. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. The intent is to provide relief from pain and nerve damage. Am J Otolaryngol. Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Spine 19(20 Suppl):2279S2296, 1994. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database.
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