Am J Orthop. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Studdert DM, Mello MM, Sage WM, et al. A total of 2396 screws were placed accurately (87.96%). 5 Those authors recommend that particular care should be taken in inserting the washers without cross threading and ensuring that they are locked down tightly, with an adequate length of rod protruding beyond the screw. Of note, the award amount for one settlement case was undisclosed. Spine 8:970981, 1996. Careers. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. J Bone Joint Surg 62A:13021307, 1980. 37. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Pedicle screw | definition of pedicle screw by Medical dictionary 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Unauthorized use of these marks is strictly prohibited. 32. Makhni MC, Park PJ, Jimenez J, et al. Moffatt-Bruce SD, Ferdinand FD, Fann JI. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 2011;365(7):629636. Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Before Figure 1: Lower thoracic pedicles provide the firm purchase of the pedicle screw from a lateral starting point and 10-15 degrees convergent angle Surgical technique "Free Hand" pedicle screw placement [50] Our "Free Hand" technique is equivalent for lumbar and What can spine surgeons do to improve patient care and avoid medical negligence suits? 2 One of the first obstacles regarding . 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. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following Spine (Phila Pa 1976). Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. Methods: Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 70% of Pedicle Screws are misplaced - orthostreams.com Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. 1. The site is secure. Five patients had uneventful early postoperative course. 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. 1). The pedicle screws judged as misplacement. a Medial minor perforation 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. Neurosurgical practice liability: relative risk by procedure type. 5. The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. Spine 18:23252326, 1993. The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . laterally placed screws and the azygous vein on the right (T5-T11). MeSH While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. 31. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). 14. Per-patient analysis reveals more concerning numbers toward screw misplacement. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. Spine (Phila Pa 1976). In order to prove medical malpractice occurred, the plaintiffs attorney needs to show not only the plaintiff experienced a poor medical outcome, but that it was directly caused by medical negligence. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Eur Spine J. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Spine 19:25842589, 1994. Re: malpositioned pedicle screw resulting in additional surgery and disability. Agarwal N, Gupta R, Agarwal P, et al. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Results. Nahed BV, Babu MA, Smith TR, Heary RF. Neurologic injury. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Am J Transl Res. St Louis, CV Mosby 322327, 1987. Ahmadi SA, Sadat H, Scheufler KM, et al. Br J Neurosurg. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. Li HM, Zhang RJ, Shen CL. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Spine 24:23522357, 1999. Your current browser may not support copying via this button. Several limitations should be carefully considered when interpreting our results. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 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. In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). Spine (Phila Pa 1976). 13. Facebook Google Plus Youtube RSS Email. Your message has been successfully sent to your colleague. 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. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). Drs. 2014;174(11):18671868. 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. 2018;43(14):984990. Introduction. . Please try after some time. Clin Orthop 203:717, 1986. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Complications and Problems Related to Pedicle Screw Fixation - LWW Personal consequences of malpractice lawsuits on American surgeons. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. 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 Elizabeth Hofheinz, M.P.H., M.Ed. Analysis and interpretation of data: Sankey, TT Than. Of note, while only 38.2% (n = 26) of cases in our study mentioned the use of intraoperative radiographic confirmation, only one of these cases reported that the misplaced screw had been caught prior to leaving the operating room, which had resulted in an inadvertent dural tear and L5 nerve root injury. Spine 13:952953, 1988. However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. Spine 6:263267, 1981. In White AH, Rothman RH, Ray CD (eds). J Neurosurg Spine. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. Malpractice claims in spine surgery in Germany: a 5-year analysis. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. 2006;65(4):416421. Bethesda, MD 20894, Web Policies Retrospective Computed Tomography Scan Analysis of Percutaneously J Neurosurg Spine. As compared to cases in 19952009, those in 20102019 resulted in a significantly higher average nominal payout to plaintiffs ($776,439 $74,460 vs $1,506,000 $385,527, p = 0.028). Health Aff (Millwood). Study design: Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Clin Orthop 227:1023, 1988. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. 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. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. All Rights Reserved. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Med Econ. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Legal liability in iatrogenic orbital injury. Median screw misplacement rate was 10% in group A and 13% in group B. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Don't jump in get legal help. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. 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. Pedicle screw placement accuracy impact and comparison between grading Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? Spine 19(20 Suppl):2279S2296, 1994. Please try again soon. 2020;45(2):E111E119. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. The medicolegal landscape of spine surgery: how do surgeons fare? Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Sethi MK, Obremskey WT, Natividad H, et al. Wolters Kluwer Health One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. 22. The amount awarded was not significantly different across US regions (p = 0.9; Fig. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). 1. Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. None of these complications resulted in additional surgery or in a significant increase of morbidity. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). 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. 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. 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. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. All the incidental dural tears were repaired immediately and produced no clinical sequelae. However, only a few complications were related to a poor clinical outcome. Comparison of pedicle screw placement accuracy between two types of Epub 2022 Oct 29. Malpractice risk according to physician specialty. The patient suffered permanent nerve damage as a result of the puncture. Spine 17:834837, 1992. 2014;21(3):320328. Despite commonly used, questions remain about their safety especially for the thoracic spine and in deformity where difficulty in positioning can lead to pedicle breach and adjacent structures injury. 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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. 2017;42(3):177185. Hardware-related failures were observed in 12 patients (10.7%). Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) 35. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. 38. Potential complications may include increased pain, infection, or mechanical . The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. Orthop Trans 11:99, 1987. 2016;102(2):358362. Fortunately, most of the complications were minor and transient. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. 2011;306(10):1088. J Bone Joint Surg 54A:11951204, 1972. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted
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