However, only a few complications were related to a poor clinical outcome. Spine 16:576579, 1991. 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. 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. Please enable scripts and reload this page. J Bone Joint Surg 73A:11791184, 1991. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Ann R Coll Surg Engl. $ = US$. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Li HM, Zhang RJ, Shen CL. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). 8,24,25,32. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Thoracic pedicle screw placement: Free-hand technique - Bioline J Pediatr Orthop. 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. 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. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. An official website of the United States government. Med Econ. Epub 2022 Oct 29. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. The screws were needed to stabilize the spine and fix the fused vertebrae in place. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Clin Orthop 203:7598, 1986. may email you for journal alerts and information, but is committed Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Routine CT scans were taken in all patients. N Engl J Med. PMC Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Percentage of cases per US region (center). 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. 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. 2009;10(1):3339. 2018;43(14):984990. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 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. 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. Potential complications may include increased pain, infection, or mechanical . 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. Summary of background data: Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Personal consequences of malpractice lawsuits on American surgeons. 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. Intraoperative pedicle fractures requiring further points of fixation. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. 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. Laryngoscope. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 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. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 15. Copyright 2023 Becker's Healthcare. pedicle screw misplacement malpractice Pullout performance comparison of pedicle screws based on cement J Neurosurg Spine. 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 23. Defendant-awarded cases by US region (right). sharing sensitive information, make sure youre on a federal Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Spine 18:983991, 1993. 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 amount awarded was not significantly different across US regions (p = 0.9; Fig. 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. Spine 16(8 Suppl):S422427, 1991. The rate of reoperation for screw misplacement per screw was 0.17%. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 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. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Federal government websites often end in .gov or .mil. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? Would you like email updates of new search results? Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. official website and that any information you provide is encrypted 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. 3. 2018;83(5):9971006. (A) Anteroposterior and (B) lateral radiographs show coronal imbalance that developed 4 years after surgery in a 57-year-old woman with L3L4 float fusion. Spine 15:1114, 1990. Patient Suffers Permanent Nerve Damage From Spinal Surgery Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Guillain A, Moncany AH, Hamel O, et al. Pedicle screw insertion in the thoracolumbar spine. Pedicle Screw Malposition Expert Witness: Malposition Can Lead to EOS System Courtesy of EOS imaging. 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. Five patients had uneventful early postoperative course. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis 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). Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. 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 suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. Some error has occurred while processing your request. 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. Pullout strength of misplaced pedicle screws in the thoracic and lumbar 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. 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. 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. 2013;32(1):111119. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. Retrospective Computed Tomography Scan Analysis of Percutaneously Clin Orthop 227:1023, 1988. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. 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. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Privacy Policy. 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. 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. 2016;25(3):716723. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. 2022 Sep 15;14(9):6323-6331. eCollection 2022. 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. Copyright © 2023 Becker's Healthcare. Svider PF, Kovalerchik O, Mauro AC, et al. Spine 24:23522357, 1999. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 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. Eur Spine J. Health Aff (Millwood). Spinal fusion procedures are increasingly performed each year, with Deyo et al. Methods. Similarly, the highest inflation-adjusted amount awarded ($2,302,472) for pseudarthrosis was attributed to a medially breached pedicle screw during an L5S1 fusion that was determined to have caused the failed union and subsequent need for revision surgery. 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. Lumbar Spine Surgery. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan Spine 19:25842589, 1994. Over 40% of patients had screws with either some/major concern. Results. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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). The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. Of note, the award amount for one settlement case was undisclosed. The medicolegal landscape of spine surgery: how do surgeons fare? 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. J Bone Joint Surg 61A:201207, 1979. However, the highest offer had been a combined $300,000 from the two defendants. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. Plaintiff-awarded cases by US region (left). McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. 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). The cost of defensive medicine on 3 hospital medicine services. 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. Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. 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. ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. J Neurosurg Spine. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. You are talking one of the most complicated area of the law. Hardware problems were those related to the physical change of metal and screw position. The plaintiff underwent revision surgery in May 2013. Show more. Rajasekaran S, Bhushan M, Aiyer S, et al. 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.
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