Pitfall: Unstable injuries. What can spine surgeons do to improve patient care and avoid medical negligence suits? Quraishi NA, Hammett TC, Todd DB, et al. The patient had to undergo a subsequent surgery to remove the pedicles. Epstein NE. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Presse Med 78:14471448, 1970. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). 23. Svider PF, Husain Q, Kovalerchik O, et al. Neurologic injury. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 15. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). Sethi MK, Obremskey WT, Natividad H, et al. ABSTRACT: Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantied in patients. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Nottmeier EW, Seemer W, Young PM. Malpractice issues in neurological surgery. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. government site. Federal government websites often end in .gov or .mil. Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. doi: 10.1097/BRS.0b013e31822a2e0a. Administrative/technical/material support: Mehta, Wang, KD Than. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Deyo RA, Mirza SK, Martin BI. The initial search using the terms above returned 3654 cases. Br J Neurosurg. Studdert DM, Mello MM, Sage WM, et al. 2014;75(6):609613. Luque ER: Segmental spinal instrumentation of lumbar spine. 15. In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 1. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). A p < 0.05 was considered statistically significant. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 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. Five patients had uneventful early postoperative course. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. shooting in valdosta leaves one dead leg pain. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. Please try again soon. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. Spine 6:263267, 1981. They both had motor deficits from which 1 patient recovered completely. A total of 69 patients (mean age, 67.416 . The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 2013;32(1):111119. 7. your express consent. Elizabeth Hofheinz, M.P.H., M.Ed. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Spine 18:18621866, 1993. 31. The site is secure. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Moffatt-Bruce SD, Ferdinand FD, Fann JI. 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. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. 2009;10(1):3339. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Preparation. Dr. Abd-El-Barr is a consultant for Spineology. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Steffee AD, Biscup RS, Sitkowski DJ: Segmental spine plates with pedicle screw fixation: A new internal fixation device for disorders of the lumbar and thoracolumbar spine. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Fishers exact test and the Mann-Whitney U-test were used for the analysis of categorical and continuous data, respectively, except when an unpaired t-test was utilized for analyses related to normalized, nominal, and inflation-adjusted award totals. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. 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. With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. 3). It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Conception and design: Sankey, KD Than. 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. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). 8,24,25,32. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. From the *Department of Orthopaedic Surgery, University of Crete Medical School, Heraklion, Greece; and the **First Department of Orthopaedics, University of Athens Medical School, Athens, Greece. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 1. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Review of neurosurgery medical professional liability claims in the United States. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. National Library of Medicine Bookshelf Pullout performance comparison of pedicle screws based on cement application and design parameters Tolga Tolunay, Cemile Bagl, Teyfik Demir, Mesut E Yaman, and Arslan K Arslan Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2015 229: 11 , 786-793 Download Citation All Rights Reserved. Cerebrospinal fluid fistulas. Epstein NE. However, the misplacement of pedicle screws can lead to disastrous complications. 2021 Jul 1;41(Suppl 1):S80-S86. J Neurosurg. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. Despite these failures, solid spinal arthrodesis was obtained in all patients. 12. 2020;162(6):13791387. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Dr. Shaffrey holds patents with, receives royalties from, and is a consultant for Medtronic, NuVasive, and Zimmer Biomet; is a stockholder in NuVasive; is a consultant for K2M, Stryker, SI Bone, and In Vivo; and has received grants from the ISSG, DePuy Synthes, and AO Spine. 2014;21(3):320328. We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. Spine 19:25842589, 1994. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. This occurred on only one side and the correction achieved by the instrumentation was maintained. 2018;29(4):397406. Makhni MC, Park PJ, Jimenez J, et al. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Wolters Kluwer Health Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. Orthopedics. A.J. Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. Spine 13:696706, 1988. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. MeSH 1). Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. The intent is to provide relief from pain and nerve damage. It has a great developing technique that is used for fixation and fusion in spine surgery. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. An official website of the United States government. 33. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Int Orthop 20:3542, 1996. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. 6. 30. 8600 Rockville Pike (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. The .gov means its official. The amount awarded was not significantly different across US regions (p = 0.9; Fig. Linking and Reprinting Policy. 20. Defendant-awarded cases by US region (right). 8. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Several limitations should be carefully considered when interpreting our results. This patient recovered completely in 6 weeks. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. The contact form sends information by non-encrypted email, which is not secure. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Orthop Trans 11:99, 1987. Spine 18:983991, 1993. Screw misplacement. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. 3. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Spine 16(8 Suppl):S422427, 1991. Steffee AD, Brantigan JW: The variable screw placement spinal fixation system: Report of a prospective study of 250 patients enrolled in Food and Drug Administration clinical trials. 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. For more information, please refer to our Privacy Policy. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 2011;213(5):657667. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. 16. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial, Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. HHS Vulnerability Disclosure, Help Am J Otolaryngol. Laryngoscope. Jena AB, Seabury S, Lakdawalla D, Chandra A. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Spine 14:472476, 1989. Intraoperative pedicle fractures requiring further points of fixation. Drafting the article: Sankey. Your current browser may not support copying via this button. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. 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. Surg Neurol Int. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 2017;27(4):470475. A total of 2396 screws were placed accurately (87.96%). Din RS, Yan SC, Cote DJ, et al. 6 2013;34(6):699705. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. This decision must be made on a case-by-case basis at the surgeons and patients discretion after a thorough discussion of the associated risks and benefits of revision surgery. 29. 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. 26. Lehmann TR, LaRocca HS: Repeat lumbar surgery: A review of patients with failure from previous lumbar surgery treated with spinal canal exploration and lumbar spine fusion. Med Econ. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation.