4. Orthop Trans 11:99, 1987. Spine 18:23252326, 1993. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. 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. Please try after some time. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Nationally Recognized Regionally Dominant Contact Us Now For a Free Consultation Over $850 Million in Verdicts and Settlements Home Articles Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Pitfall: Unstable injuries. Clinical Orthopaedics and Related Research411:86-94, June 2003. 2012;21(suppl 2):S196S199. J Bone Joint Surg 73A:11791184, 1991. Administrative/technical/material support: Mehta, Wang, KD Than. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, 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, 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, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, 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, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. This occurred on only one side and the correction achieved by the instrumentation was maintained. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 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. Guillain A, Moncany AH, Hamel O, et al. Mason A, Paulsen R, Babuska JM, et al. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Cerebrospinal fluid fistulas. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. J Neurosurg Spine. Smith TR, Hulou MM, Yan SC, et al. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 15. Am J Orthop. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. 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. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. 38. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. 2017;27(4):470475. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Svider PF, Husain Q, Kovalerchik O, et al. Methods: George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 2012 Feb 1;37(3):E188-94. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. None of these complications resulted in additional surgery or in a significant increase of morbidity. Pullout performance comparison of pedicle screws based on cement 33. may email you for journal alerts and information, but is committed 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. 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. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. PLoS One. 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. Study design: What can spine surgeons do to improve patient care and avoid medical negligence suits? A total of 2724 screws were placed in 127 patients. + 48 696 042 504. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 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. 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. JAMA. Fager CA. Pullout strength of misplaced pedicle screws in the thoracic and lumbar Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Patient-specific 3D-printed surgical guides for pedicle screw insertion 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. 3. 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. Level of evidence: Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Each side was judged separately. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Spine 18:983991, 1993. Defensive medicine in neurosurgery: the Canadian experience. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Results. Makhni MC, Park PJ, Jimenez J, et al. 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. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. doi: 10.1097/BRS.0b013e31822a2e0a. 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. The screws were needed to stabilize the spine and fix the fused vertebrae in place. 3). Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Spine 17:834837, 1992. 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. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Surg Neurol Int. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Would you like email updates of new search results? Clin Orthop 203:717, 1986. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. N Engl J Med. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Spine (Phila Pa 1976). Potential complications may include increased pain, infection, or mechanical . 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Rynecki ND, Coban D, Gantz O, et al. Robotic-assisted pedicle screw placement fails to reduce overall Spine 16(8 Suppl):S422427, 1991. Thoracic Pedicle Screws - ScienceDirect Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. HHS Vulnerability Disclosure, Help 2020;162(6):13791387. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. Spine (Phila Pa 1976). to maintaining your privacy and will not share your personal information without Health Aff (Millwood). Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Elizabeth Hofheinz, M.P.H., M.Ed. J Am Coll Surg. Introduction. Neurosurgical practice liability: relative risk by procedure type. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. 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. Rothberg MB, Class J, Bishop TF, et al. * In the remaining patients, the standard construct was three-segment fixation spanning four vertebrae and three discs, two above and one below the fractured vertebra, using six screws. In the other patient, L4L5 float arthrodesis was done. J Bone Joint Surg 54A:11951204, 1972. 4. 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. 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. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. 20. Spine 24:23522357, 1999. 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. 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. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. 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. 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). 26. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. 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. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. 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. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Complications and Problems Related to Pedicle Screw Fixation - LWW 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Epstein NE. 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. 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. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Five patients had uneventful early postoperative course. 2018;27(9):23392347. 2,24,28,36. However, the highest offer had been a combined $300,000 from the two defendants. Please enable it to take advantage of the complete set of features! 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. 11. It has a great developing technique that is used for fixation and fusion in spine surgery. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Epstein NE. Both of these patients complained of thigh pain but refused any additional surgery. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 0 attorneys agreed. 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. Facebook Google Plus Youtube RSS Email. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. States were then grouped by US region and case year by 5-year intervals. 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. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. 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. In six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. Ahmadi SA, Sadat H, Scheufler KM, et al. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. J Spine Surg. Defendant-awarded cases by US region (right). All case demographics are summarized in Table 1. 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). Todd NV. NCI CPTC Antibody Characterization Program. The initial search using the terms above returned 3654 cases. 2014;75(6):609613. Acquisition of data: Sankey. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one.