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Eur Spine J. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. PMC N Engl J Med. Nayar G, Blizzard DJ, Wang TY, et al. J Neurosurg Spine. 2012 Feb 1;37(3):E188-94. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Cookie Policy. 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. Thus, in the current study we aimed to describe this impact in the US, as well as to suggest a potential method for mitigating the problem. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Copyright 2023 Becker's Healthcare. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Am J Transl Res. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. J Spinal Disord Tech. 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). Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. Level of evidence: Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. 10. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 11. Li HM, Zhang RJ, Shen CL. 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. 30. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Disclaimer. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Lali Sekhon, Jocelyn Idema & more: 4 spine and neurosurgeons making headlines, Spinal cord stimulation trumps medication for pain reduction 7 takeaways, Dr. Khalid Kurtom on major trends in spinal cord injury surgery. Dr. Shaffrey has received grants from the NIH and Department of Defense. 12. 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. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 2012;89(10):7071. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Personal consequences of malpractice lawsuits on American surgeons. 2021 Jul 1;41(Suppl 1):S80-S86. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Spine 6:263267, 1981. Health Aff (Millwood). Characteristics of medicolegal cases related to misplaced screws in spine surgery. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. 1. official website and that any information you provide is encrypted The initial search using the terms above returned 3654 cases. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Ahmadi SA, Sadat H, Scheufler KM, et al. A total of 69 patients (mean age, 67.416 . A large number of studies have reported that in conventional thoracolumbar surgery, compared with traditional freehand screw placement, the accuracy of intraoperative pedicle screw placement has been improved with O-arm intraoperative navigation technology. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Spine 16(8 Suppl):S455458, 1991. An official website of the United States government. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Re: malpositioned pedicle screw resulting in additional surgery and disability. Acquisition of data: Sankey. A.J. Patient safety: disclosure of medical errors and risk mitigation. 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 . GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Show more. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. 2011;365(7):629636. J Bone Joint Surg 61A:201207, 1979. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. This patient recovered completely in 6 weeks. J Neurosurg Spine. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). None of these complications resulted in additional surgery or in a significant increase of morbidity. 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). Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. 15. 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. sharing sensitive information, make sure youre on a federal 29. This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. All Rights Reserved. The medicolegal landscape of spine surgery: how do surgeons fare? Seabury SA, Chandra A, Lakdawalla DN, Jena AB. JAMA. Despite this problem, the clinical result was excellent. J Neurosurg Spine. NCI CPTC Antibody Characterization Program. Summary of background data: demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. The contact form sends information by non-encrypted email, which is not secure. 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%. Median screw misplacement rate was 10% in group A and 13% in group B. 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. Smith TR, Hulou MM, Yan SC, et al. 2011;24(1):1519. Spine 6:615619, 1981. 2018;43(14):984990. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). South Med J 62:17, 1969. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . 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. You are talking one of the most complicated area of the law. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 1). Percentage of cases per US region (center). Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. Yuan et al 37 reported that the use of spinal instrumentation is associated with higher rate of infection (3%6%), neurologic injury (1%5%), instrumentation failure (6%10%), and reoperation (20%), compared with in situ arthrodeses. 24. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. A misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 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. Spine (Phila Pa 1976). Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 2017;27(4):470475. Dr. Abd-El-Barr is a consultant for Spineology. 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. 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. 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. Rather, the defense demonstrated that although the misplaced screw had in fact irritated the L4 nerve root for the six days before it was removed, the related symptoms resolved with the screws removal. 1. Hardware-related failures were observed in 12 patients (10.7%). The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Friedlander and Bradley will pay half of the $2.25 million. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. Unauthorized use of these marks is strictly prohibited. Spine 15:908912, 1990. 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 Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. 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. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. 2018;41(5):e615e620. Over 40% of patients had screws with either some/major concern. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. 2014;20(2):196203. Med Econ. 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. The patient suffered permanent nerve damage as a result of the puncture.