30. Smith TR, Hulou MM, Yan SC, et al. 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. 2013;123(9):20992103. Guillain A, Moncany AH, Hamel O, et al. Clinical Orthopaedics and Related Research, Get new journal Tables of Contents sent right to your email inbox, The Association of Bone and Joint Surgeons, Complications and Problems Related to Pedicle Screw Fixation of the Spine, Articles in Google Scholar by Pavlos Katonis, MD, Other articles in this journal by Pavlos Katonis, MD, Privacy Policy (Updated December 15, 2022). 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. Epub 2021 Aug 28. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 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. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 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. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Plaintiff-awarded cases by US region (left). Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Mason A, Paulsen R, Babuska JM, et al. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. 2018;27(9):23392347. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. 5. 2. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Clin Orthop 203:717, 1986. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 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. 28. A large number of studies have reported that in conventional thoracolumbar surgery, compared with traditional freehand screw placement, the accuracy of intraoperative pedicle screw placement has been improved with O-arm intraoperative navigation technology. The amount awarded was not significantly different across US regions (p = 0.9; Fig. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. In White AH, Rothman RH, Ray CD (eds). National Library of Medicine 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. Am J 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. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. Defensive medicine: a culprit in spiking healthcare costs. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. 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). Rajasekaran S, Bhushan M, Aiyer S, et al. Personal consequences of malpractice lawsuits on American surgeons. 2014;174(11):18671868. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . + 48 696 042 504. 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. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. Epub 2014 Jun 13. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. Clipboard, Search History, and several other advanced features are temporarily unavailable. 15. 35. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. 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. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 26. 2002;27(22):24252430. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Re: malpositioned pedicle screw resulting in additional surgery and disability. And while the jury debated for about two hours, at the end of its deliberation it sided with the defendants and entered a not guilty verdict. The initial search using the terms above returned 3654 cases. 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). 24. sharing sensitive information, make sure youre on a federal Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Statistical analysis: Sankey. 2009;10(1):3339. J Bone Joint Surg 61A:201207, 1979. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. 2014;96(4):266270. 31. Deyo RA, Mirza SK, Martin BI. 2018;29(4):397406. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). EOS System Courtesy of EOS imaging. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). 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. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. Level of evidence: 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? J Spine Surg. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Agarwal N, Gupta R, Agarwal P, et al. . Spine 19(20 Suppl):2279S2296, 1994. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . 2 One of the first obstacles regarding . 4. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. 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. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 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. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Accessibility 6. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Five patients had uneventful early postoperative course. Can Postoperative Radiographs Accurately Identify Screw Misplacements? 2012;41(2):6973. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Eur Spine J. 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. 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. Spine 18:23252326, 1993. Spine (Phila Pa 1976). Defensive medicine in U.S. spine neurosurgery. Methods. The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. 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. Of note, the award amount for one settlement case was undisclosed. Results. Spine 15:1114, 1990. Legal liability in iatrogenic orbital injury. Your current browser may not support copying via this button. 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. Spine 16(8 Suppl):S422427, 1991. Each side was judged separately. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. None of these complications resulted in additional surgery or in a significant increase of morbidity. 2018;41(5):e615e620. Spine 17:349355, 1992. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Clin Orthop 203:126134, 1986. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. Jena AB, Seabury S, Lakdawalla D, Chandra A. Spinal fusion procedures are increasingly performed each year, with Deyo et al. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 17. Clinical Orthopaedics and Related Research411:86-94, June 2003. Spine 13:10121018, 1988. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. 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. However, the misplacement of pedicle screws can lead to disastrous complications. The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. 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 ]. Linking and Reprinting Policy. Schatlo B, Molliqaj G, Cuvinciuc V, et al. This site needs JavaScript to work properly. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. doi: 10.1097/BPO.0000000000001828. The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. 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. Todd NV. MeSH 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. JAMA. 16. Spine Deform. 2018;18(2):209215. Malpractice litigation following spine surgery. Drafting the article: Sankey. Despite this problem, the clinical result was excellent. 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. Svider PF, Kovalerchik O, Mauro AC, et al. Surg Neurol Int. Svider PF, Husain Q, Kovalerchik O, et al. Spine (Phila Pa 1976). 23. 3). Makhni MC, Park PJ, Jimenez J, et al. 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. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. official website and that any information you provide is encrypted Please try again soon. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. These numbers are in line with the current literature. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Dr. Shaffrey has received grants from the NIH and Department of Defense. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). 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). 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.