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. Pedicle screw accuracy in thoracolumbar fractures- is routine What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. Over 40% of patients had screws with either some/major concern. Malpractice risk according to physician specialty. Epub 2022 Oct 29. However, only a few complications were related to a poor clinical outcome. (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. 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. 26. 2013;123(9):20992103. Spine (Phila Pa 1976). 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. 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. Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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 ]. Accessibility Rynecki ND, Coban D, Gantz O, et al. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 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. Malpractice issues in neurological surgery. 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. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. Patient safety: disclosure of medical errors and risk mitigation. Would you like email updates of new search results? Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 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. The https:// ensures that you are connecting to the Thoracic pedicle screw placement: Free-hand technique - Bioline 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. A p < 0.05 was considered statistically significant. 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. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Spine (Phila Pa 1976). Dr. Abd-El-Barr is a consultant for Spineology. 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 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. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 22. 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. J Spine Surg. sharing sensitive information, make sure youre on a federal 1. Luque ER: Segmental spinal instrumentation of lumbar spine. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Guillain A, Moncany AH, Hamel O, et al. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. 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. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. 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 J. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. In White AH, Rothman RH, Ray CD (eds). The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Problems of balance were coronal (scoliosis greater than 5 or trunk shift greater than 5 mm) as seen on the AP radiograph taken with the patient standing or sagittal (failure to obtain or maintain lumbar lordosis). However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. 36. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. A total of 2396 screws were placed accurately (87.96%). J Bone Joint Surg 62A:13021307, 1980. PMC 2018;41(5):e615e620. Spine 8:970981, 1996. 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. Under the high-low agreement, Drs. government site. 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. 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. shooting in valdosta leaves one dead McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. 2020;45(2):E111E119. 2002;27(22):24252430. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Am J Orthop. 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 The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. 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. Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . Li HM, Zhang RJ, Shen CL. J Bone Joint Surg 45A:11591170, 1963. 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. 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. 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. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. 5. Spine 6:263267, 1981. Copyright © 2023 Becker's Healthcare. 10. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. 2005;293(21):26092617. 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. N Engl J Med. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Pedicle screw replacement in spinal surgery - The MDU 16. One hundred four of the 112 patients had a posterior procedure. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. 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. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. 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. 2018;29(4):397406. The pedicle screws judged as misplacement. a Medial minor perforation The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. HHS Vulnerability Disclosure, Help Of note, the award amount for one settlement case was undisclosed. 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. 2012;37(1):6776. Clipboard, Search History, and several other advanced features are temporarily unavailable. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Bethesda, MD 20894, Web Policies West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. 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. Acquisition of data: Sankey. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 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. Spine 19:25842589, 1994. However, the misplacement of pedicle screws can lead to disastrous complications. The contact form sends information by non-encrypted email, which is not secure. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Nayar G, Blizzard DJ, Wang TY, et al. 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. 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. Drs. 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. The patient had to undergo a subsequent surgery to remove the pedicles. Each case was then carefully screened for relevance and sufficient data. single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement Defendant-awarded cases by US region (right). 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). 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. You are talking one of the most complicated area of the law. Patient-specific 3D-printed surgical guides for pedicle screw insertion + 48 696 042 504. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. Several limitations should be carefully considered when interpreting our results. 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. 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. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). The average followup was 35 months (range, 1851 months). Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Pitfall: Unstable injuries. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 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). 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. Malpositioned pedicle screw resulting | Legal Advice - LawGuru 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Study design: Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. 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. 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. Eur Spine J. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. 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. Hardware problems were those related to the physical change of metal and screw position. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 37. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. 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. Thoracic Pedicle Screws - ScienceDirect 2011;24(1):1519. All case demographics are summarized in Table 1. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. 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. 11. However, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. Nottmeier EW, Seemer W, Young PM. South Med J 62:17, 1969. The medicolegal landscape of spine surgery: how do surgeons fare? Results: A total of 2724 screws were placed in 127 patients. Friedlander and Bradley will pay half of the $2.25 million.
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