5. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Results. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Epub 2014 Jun 13. The third patient, who had central spinal stenosis, was treated by decompression alone. 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. Forty-seven general complications were seen in 41 patients (36.5%). A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted Mason A, Paulsen R, Babuska JM, et al. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 4. All the incidental dural tears were repaired immediately and produced no clinical sequelae. The cost of defensive medicine on 3 hospital medicine services. Despite this problem, the clinical result was excellent. 16. Epstein NE. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. 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. Conception and design: Sankey, KD Than. General complications were considered those developing during and after surgery that were not directly related to instrumentation. 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. (%), Pseudarthrosis requiring revision surgery. pedicle screws sagittal alignment spinal fusion surgical guides Spinal fusion is used to treat a range of conditions associated with spinal column such as intervertebral disc degeneration and scoliosis [ 1 ]. Reviewed submitted version of manuscript: all authors. Spine 18:18621866, 1993. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. South Med J 62:17, 1969. Personal consequences of malpractice lawsuits on American surgeons. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Spine 19(20 Suppl):2279S2296, 1994. 11. The screws were needed to stabilize the spine and fix the fused vertebrae in place. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). 2019;19(7):12211231. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction St Louis, CV Mosby 322327, 1987. 2014;20(6):636643. All the operations were done by one surgeon (PK). Please enable scripts and reload this page. Study design: The average followup was 35 months (range, 1851 months). may email you for journal alerts and information, but is committed The link was not copied. 4. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. 2018;43(14):984990. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Clin Orthop 203:717, 1986. One hundred twelve consecutive patients were entered into a retrospective study of instrumented thoracolumbar, lumbar, and lumbosacral spinal arthrodesis at our institution, between September 1994 and January 1999. 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. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. 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. 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. 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. Spine 15:908912, 1990. 20. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. 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. 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. 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. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 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. . All case demographics are summarized in Table 1. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. 17. 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. Spine 13:952953, 1988. 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. 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. Spine 16:576579, 1991. 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. Clin Orthop 203:7598, 1986. 144 Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Clin Orthop 227:1023, 1988. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Malpractice issues in neurological surgery. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 2012;41(2):6973. Thoracic pedicle screw placement: Free-hand technique - Bioline Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. PMC The pedicle screws judged as misplacement. a Medial minor perforation Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 3. 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. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Insuring spinal neurosurgery. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Smith TR, Hulou MM, Yan SC, et al. Of note, the award amount for one settlement case was undisclosed. Deyo RA, Mirza SK, Martin BI. 2011;365(7):629636. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. 2018;28(2):186193. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. were excluded from analysis. Review of neurosurgery medical professional liability claims in the United States. (PDF) Lumbosacral pedicle screw placement using a fluoroscopic pedicle Clin Orthop 203:4553, 1986. 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. PLoS One. Acquisition of data: Sankey. Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Complications and Problems Related to Pedicle Screw Fixation - LWW Elizabeth Hofheinz, M.P.H., M.Ed. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 31. 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. 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. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. National Library of Medicine In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 2 One of the first obstacles regarding . 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. leg pain. Eur Spine J. N Engl J Med. Scarone P, Vincenzo G, Distefano D, et al. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. Median screw misplacement rate was 10% in group A and 13% in group B. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. 8,24,25,32. 2,24,28,36. Hecht N, Kamphuis M, Czabanka M, et al. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 2020;162(6):13791387. JAMA. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). JAMA. Cookie Policy. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). We serve the following localities: Cook County including Arlington Heights, Barrington, Berwyn Township, Chicago, Des Plaines, Glenview, Orland Park, Palos Park, Schaumburg, and Tinley Park; DuPage County including Downers Grove, Naperville, and Bolingbrook; Kane County including Aurora, Elgin and Geneva; Lake County including Waukegan; and Will County including Joliet. Privacy Policy. Pitfall: Unstable injuries. 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. Orthopedics. J Bone Joint Surg 73A:11791184, 1991. J Neurosurg Spine. 2013;34(6):699705. J Bone Joint Surg 61A:201207, 1979. 18. Neurosurgical practice liability: relative risk by procedure type. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. 2. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Surg Neurol Int. The https:// ensures that you are connecting to the Call me tomorrow. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. 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. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. 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. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 24. Clinical Orthopaedics and Related Research411:86-94, June 2003. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. Screw misplacement. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. 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. Five patients had uneventful early postoperative course. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Health Aff (Millwood). 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. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. The initial search using the terms above returned 3654 cases. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Spine Deform. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Rovit RL, Simon AS, Drew J, et al. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Spine 18:983991, 1993. Spinal fusion procedures are increasingly performed each year, with Deyo et al. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. All Rights Reserved. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. It has a great developing technique that is used for fixation and fusion in spine surgery. In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? Neurological Outcome and Management of Pedicle Screws Misplaced Totally
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