Smith TR, Hulou MM, Yan SC, et al. Ann Thorac Surg. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Spine 18:18621866, 1993. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. Scarone P, Vincenzo G, Distefano D, et al. Facebook Google Plus Youtube RSS Email. The https:// ensures that you are connecting to the Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. 2007;106(6):11081114. Epub 2021 Aug 28. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. J Neurosurg Spine. A rod is used to hold the vertebra together to allow fusion to occur. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Neurosurgery. 33. Br J Neurosurg. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Of note, the award amount for one settlement case was undisclosed. Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. 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. Lumbar Spine Surgery. MeSH JAMA Intern Med. Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature. Results: Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Am J Orthop. PMC Defensive medicine in neurosurgery: the Canadian experience. Clinical Orthopaedics and Related Research, Get new journal Tables of Contents sent right to your email inbox, The Association of Bone and Joint Surgeons, Complications and Problems Related to Pedicle Screw Fixation of the Spine, Articles in Google Scholar by Pavlos Katonis, MD, Other articles in this journal by Pavlos Katonis, MD, Privacy Policy (Updated December 15, 2022). Clin Orthop 115:130139, 1976. Dr. Abd-El-Barr is a consultant for Spineology. shooting in valdosta leaves one dead Fager CA. 4. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. Spine 8:970981, 1996. 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. Your message has been successfully sent to your colleague. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. An official website of the United States government. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 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. The link was not copied. 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. 2002;27(22):24252430. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Re: malpositioned pedicle screw resulting in additional surgery and disability. 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. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Each case was then carefully screened for relevance and sufficient data. Neurologic injury. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. Conception and design: Sankey, KD Than. Spine 6:263267, 1981. Plaintiff-awarded cases by US region (left). Linking and Reprinting Policy. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. 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. 3. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Rothberg MB, Class J, Bishop TF, et al. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. Clin Orthop 203:7598, 1986. 2018;28(2):186193. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 26. South Med J 62:17, 1969. Administrative/technical/material support: Mehta, Wang, KD Than. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. The rate of medical complications was 8%. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). In six patients (5.3%) with degenerative spine disease, the disc material had been removed. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt J Spinal Disord Tech. Agarwal N, Gupta R, Agarwal P, et al. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 144 It is indicated that screws medially misplaced at a distance greater than 2-mm, especially 4 mm, may be a cause of negative effects on the neural structure and should be removed during the early phase of the postoperative period, even among patients without postoperative neurological abnormalities. Rovit RL, Simon AS, Drew J, et al. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Clipboard, Search History, and several other advanced features are temporarily unavailable. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. may email you for journal alerts and information, but is committed Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Malpractice risk according to physician specialty. Your current browser may not support copying via this button. Don't jump in get legal help. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Percentage of cases per US region (center). J Pediatr Orthop. 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). The amount awarded was not significantly different across US regions (p = 0.9; Fig. Conclusion: 2012 Feb 1;37(3):E188-94. J Bone Joint Surg 62A:13021307, 1980. Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . 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. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Clin Orthop 203:717, 1986. Defensive medicine: a culprit in spiking healthcare costs. Neurosurgery. Nyquist followed a medical malpractice lawsuit against Dr. Masnyk for his surgical error, alleging that the surgeon had improperly positioned the right L4 pedicel screw which had resulted in a nerve root injury and Nyquists subsequent foot drop. Under the high-low agreement, Drs. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 25. 1. 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. Neurosurgeons and orthopedic surgeons were named as the defendant in an equal number of cases, and the decision for the plaintiff versus the defendant was also similar between specialties. government site. 5. J Neurosurg Spine. 22. 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. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. In four of these patients, bent screws occurred at 8 to 10 months after surgery; in three patients, broken screw necks were seen 1 year after surgery and in two patients, tulip screw plug dislodgments were observed at 4 and 6 months postoperatively, respectively. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 32. 2018;83(5):9971006. 2012;7(6):e39237. 2011;24(1):1519. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. What can spine surgeons do to improve patient care and avoid medical negligence suits? 3). Spine 16(8 Suppl):S422427, 1991. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. The accuracy of pedicle screw placement using intraoperative image guidance systems. For more information, please refer to our Privacy Policy. 2017;42(3):177185. Intraoperative pedicle fractures requiring further points of fixation. 24. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Spine Deform. 3. 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. 15. 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. Med Econ. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Am J Transl Res. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Studdert DM, Mello MM, Sage WM, et al. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. The third patient, who had central spinal stenosis, was treated by decompression alone. 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. 2. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. 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. Drs. Copyright © 2023 Becker's Healthcare. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. Epub 2022 Oct 29. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 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. Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. Pitfall: Unstable injuries. 2. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. PLoS One. This site needs JavaScript to work properly. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. 2012;21(suppl 2):S196S199. 5. Spine 18:983991, 1993. Bookshelf J Neurosurg Spine. 2018;43(14):984990. 14. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. 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 Some error has occurred while processing your request. A total of 2724 screws were placed in 127 patients. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. 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. Introduction. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 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. * When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. None of these complications resulted in additional surgery or in a significant increase of morbidity. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 2. 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). 4). 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. 8600 Rockville Pike Presse Med 78:14471448, 1970. Spine (Phila Pa 1976). 2013;123(9):20992103. Both of these patients complained of thigh pain but refused any additional surgery. and 17.1% of the patients included had at least one screw misplaced. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Over 40% of patients had screws with either some/major concern. 10. Patient safety: disclosure of medical errors and risk mitigation. JAMA. Eur Spine J. 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. 2020;11:38. 2018;41(5):e615e620. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. 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. A.J. Nottmeier EW, Seemer W, Young PM. Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. 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. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws.