Drs. Sethi MK, Obremskey WT, Natividad H, et al. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Spine 16(8 Suppl):S455458, 1991. 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. Spine 18:11601172, 1993. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. 2017;31(3):287288. 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. 2014;174(11):18671868. 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. 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. Pullout performance comparison of pedicle screws based on cement PMC This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. 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. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Analysis and interpretation of data: Sankey, TT Than. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Of note, the award amount for one settlement case was undisclosed. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to 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. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). Am J Transl Res. 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. Complications and Problems Related to Pedicle Screw Fixation - LWW Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Spine 17:349355, 1992. 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. Statistical analysis: Sankey. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. Spine 6:615619, 1981. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Defensive medicine: a culprit in spiking healthcare costs. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. What can spine surgeons do to improve patient care and avoid medical negligence suits? 2014;21(3):320328. Hardware-related failures were observed in 12 patients (10.7%). 2013;123(9):20992103. 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. 144 The link was not copied. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 2014;75(6):609613. 26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. 18. pedicle screw misplacement malpractice Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Clin Orthop 115:130139, 1976. Fager CA. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Segal J. National Library of Medicine Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. J Pediatr Orthop. This patient recovered completely in 6 weeks. Careers. Epub 2022 Oct 29. 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. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 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. The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. All the operations were done by one surgeon (PK). Ahmadi SA, Sadat H, Scheufler KM, et al. 2019;19(7):12211231. PLoS One. 5. Spine (Phila Pa 1976). Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Fortunately, most of the complications were minor and transient. You are talking one of the most complicated area of the law. (%), Pseudarthrosis requiring revision surgery. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Results. 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. Instead, the defense offered up an alternative explanation for Nyquists foot drop. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 26. Spine 13:10121018, 1988. The contact form sends information by non-encrypted email, which is not secure. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. 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. 2016;25(3):716723. 4. 2018;43(14):984990. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Your current browser may not support copying via this button. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Neurological outcome and management of pedicle screws - PubMed 30. 35. Thoracic pedicle screw placement: Free-hand technique - Bioline 29. 4). Each side was judged separately. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Defendant-awarded cases by US region (right). Deyo RA, Mirza SK, Martin BI. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Thu, May 27th, 2021. Spine (Phila Pa 1976). Clin Orthop 227:1023, 1988. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect Spine 16(8 Suppl):S422427, 1991. 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 2014;20(6):636643. 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. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 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. 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. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. 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. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Malpractice risk according to physician specialty. Accessibility Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed 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. 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. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. CT-navigation versus fluoroscopy-guided placement of pedicle screws at 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. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 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. Malpositioned pedicle screw resulting | Legal Advice - LawGuru 2012 Feb 1;37(3):E188-94. Spine 8:970981, 1996. Makhni MC, Park PJ, Jimenez J, et al. 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. Nahed BV, Babu MA, Smith TR, Heary RF. 25. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). 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. Intraoperative pedicle fractures requiring further points of fixation. Med Econ. The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Pedicle screw insertion - AO Foundation 2. In the other patient, L4L5 float arthrodesis was done. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. 13. 2. 17. Plaintiff-awarded cases by US region (left). A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Reviewed submitted version of manuscript: all authors. States were then grouped by US region and case year by 5-year intervals. 27. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. Spine 15:1114, 1990. 33. Laryngoscope. Malpractice litigation following spine surgery. Unauthorized use of these marks is strictly prohibited. 2012;89(10):7071. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. HHS Vulnerability Disclosure, Help 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). Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Malpractice claims in spine surgery in Germany: a 5-year analysis. St Louis, CV Mosby 322327, 1987. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. The cost of defensive medicine on 3 hospital medicine services. Pedicle screw placement accuracy impact and comparison between grading 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. 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.
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