Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Epub 2022 Oct 29. MeSH All Rights Reserved. N Engl J Med. Spine 16(8 Suppl):S422427, 1991. This occurred on only one side and the correction achieved by the instrumentation was maintained. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. 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. 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. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 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. JAMA Intern Med. 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. 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). 2016;102(2):358362. 7. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Eur Spine J. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Presse Med 78:14471448, 1970. Would you like email updates of new search results? Malpractice litigation following spine surgery. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. The rate of reoperation for screw misplacement per screw was 0.17%. 2013;32(1):111119. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 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. Administrative/technical/material support: Mehta, Wang, KD Than. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Cookie Policy. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. 38. 2011;365(7):629636. Eur Spine J. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. Clipboard, Search History, and several other advanced features are temporarily unavailable. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. 2012;7(6):e39237. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. Spine 17:834837, 1992. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. The initial search using the terms above returned 3654 cases. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. your express consent. Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. A.J. In their meta-analysis of nine randomized controlled trials, Li et al. 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. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 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. 2019;19(7):12211231. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 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. Hecht N, Kamphuis M, Czabanka M, et al. Rajasekaran S, Bhushan M, Aiyer S, et al. 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 Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. 35. J Neurosurg Spine. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. 2002;27(22):24252430. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. 2011;306(10):1088. 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. 18. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 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. Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). 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. Linking and Reprinting Policy. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). 27. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. J Neurosurg Spine. 21. The intent is to provide relief from pain and nerve damage. The site is secure. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. 2016;124(5):15241530. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. This site needs JavaScript to work properly. Dr. Abd-El-Barr is a consultant for Spineology. 2,24,28,36. The third patient, who had central spinal stenosis, was treated by decompression alone. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). Results. Dr. Shaffrey has received grants from the NIH and Department of Defense. The patient had to undergo a subsequent surgery to remove the pedicles. reporting that the number of Medicare patients who underwent a complex lumbar spine fusion for spinal stenosis increased 15-fold, from 1.3 persons per 100,000 Medicare persons in 2002 to 19.9 in 2007.31 Similarly, a study by Rajaee et al. 2014;174(11):18671868. 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). Facebook Google Plus Youtube RSS Email. 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 Please enable it to take advantage of the complete set of features! The medicolegal landscape of spine surgery: how do surgeons fare? First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. 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. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. 2014;96(4):266270. 16. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 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. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . EOS System Courtesy of EOS imaging. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Clinical Orthopaedics and Related Research411:86-94, June 2003. 3. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. FOIA One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Acta Neurochir (Wien). Hardware-related failures were observed in 12 patients (10.7%). Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Introduction. Median screw misplacement rate was 10% in group A and 13% in group B. 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. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. 12. Per-patient analysis reveals more concerning numbers toward screw misplacement. Surg Neurol Int. 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. and transmitted securely. 33. 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. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. NCI CPTC Antibody Characterization Program. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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. 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. 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. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Spine 14:472476, 1989. Summary of background data: 1. Careers. Spine 6:615619, 1981. 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. 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. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658.