Taylor CL. Spine Deform. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. 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;75(6):609613. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. 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. 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. Drs. (%), Pseudarthrosis requiring revision surgery. Br J Neurosurg. JAMA. 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. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction States were then grouped by US region and case year by 5-year intervals. Intraoperative pedicle fractures requiring further points of fixation. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. Spine 18:23252326, 1993. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Data is temporarily unavailable. Please enable it to take advantage of the complete set of features! 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. A p < 0.05 was considered statistically significant. Your current browser may not support copying via this button. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. 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). Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 2005;293(21):26092617. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. 13. 2012;41(2):6973. Daniels AH, Ruttiman R, Eltorai AEM, et al. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 All Rights Reserved. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Defensive medicine: a culprit in spiking healthcare costs. Several limitations should be carefully considered when interpreting our results. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Under the high-low agreement, Drs. 2009;10(1):3339. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. J Neurosurg Spine. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan 2022 Sep 15;14(9):6323-6331. eCollection 2022. Jena AB, Seabury S, Lakdawalla D, Chandra A. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. 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. Hardware-related failures were observed in 12 patients (10.7%). 11. What can spine surgeons do to improve patient care and avoid medical negligence suits? Nottmeier EW, Seemer W, Young PM. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. A total of 2724 screws were placed in 127 patients. South Med J 62:17, 1969. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. * However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . None of these complications resulted in additional surgery or in a significant increase of morbidity. They both had motor deficits from which 1 patient recovered completely. Li HM, Zhang RJ, Shen CL. J Neurosurg Spine. Preparation. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Plaintiff-awarded cases by US region (left). In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? I won't be at the office but I will check my voice mail. 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. J Spinal Disord Tech. J Neurosurg. 2014;21(3):320328. J Bone Joint Surg 62A:13021307, 1980. 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. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. J Neurosurg Spine. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Some error has occurred while processing your request. Copyright 2023 Becker's Healthcare. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. 2011;306(10):1088. Deyo RA, Mirza SK, Martin BI. Federal government websites often end in .gov or .mil. Hardware problems were those related to the physical change of metal and screw position. Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 2. 2020;11:38. 2 One of the first obstacles regarding . 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. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Despite these failures, solid spinal arthrodesis was obtained in all patients. 2012 Feb 1;37(3):E188-94. Spine 8:970981, 1996. 2018;43(14):984990. Neurosurgeons and orthopedic surgeons were named as the defendant in an equal number of cases, and the decision for the plaintiff versus the defendant was also similar between specialties. 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. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Thoracic Pedicle Screws - ScienceDirect 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). 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. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. 39. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. pedicle screw misplacement malpractice All Rights Reserved. Spine 18:11601172, 1993. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. 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. Please try again soon. 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%). 12. 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 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. 31. This patient recovered completely in 6 weeks. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Clinical Orthopaedics and Related Research411:86-94, June 2003. 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. 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. Accuracy of C2 pedicle screw placement using the anatomic freehand + 48 696 042 504. 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. 2014;20(6):636643. Pitfall: Unstable injuries. J Am Coll Surg. JAMA. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. your express consent. Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis 2. Nahed BV, Babu MA, Smith TR, Heary RF. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Comparison of pedicle screw placement accuracy between two types of When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. J Neurosurg. government site. Pedicle screw placement: Robotic assistance for greater precision 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. J Neurosurg Spine. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Of note, the award amount for one settlement case was undisclosed. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. J Neurosurg Spine. Clin Orthop 203:7598, 1986. 2006;65(4):416421. 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). 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). Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Conclusion: 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. Malpractice liability and defensive medicine: a national survey of neurosurgeons. 22. 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. The average age of the patients was 47 years and the average followup was 35 months. 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). Personal consequences of malpractice lawsuits on American surgeons. Patient-specific 3D-printed surgical guides for pedicle screw insertion 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. 2021 Jul 1;41(Suppl 1):S80-S86. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Clin Orthop 203:4553, 1986. 2018;83(5):9971006. 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. This site needs JavaScript to work properly. 14. 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. 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. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine 3). Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Insuring spinal neurosurgery. 70% of Pedicle Screws are misplaced - orthostreams.com Importantly, these advanced technologies are not always readily available or the standard of care and cannot supplant a thorough understanding of operative anatomy, a high-quality surgical technique, and general complication-avoidance measures. 5. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 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 Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. 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. Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. 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 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. leg pain. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. Spine J. Critically revising the article: all authors. Pedicle screw insertion techniques: an update and review of the Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . Spine 19:25842589, 1994. 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. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. 8600 Rockville Pike 2017;27(4):470475. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 2014;96(4):266270. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 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. Rothberg MB, Class J, Bishop TF, 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. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. These numbers are in line with the current literature. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 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. 2013;123(9):20992103. 2019;19(7):12211231. Analysis and interpretation of data: Sankey, TT Than. Conversely, Nyquists foot drop did not resolve after the screw was removed, which begged the question of whether the foot drop was in fact caused by the misplaced screw. 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. 2011;24(1):1519. Spine 17:834837, 1992. 36. 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. The patient suffered permanent nerve damage as a result of the puncture. Pedicle screw | definition of pedicle screw by Medical dictionary Spine (Phila Pa 1976). Delayed open treatment of aortic penetration by a thoracic pedicle L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. Are We Underestimating the Significance of Pedicle Screw Misplacement Svider PF, Kovalerchik O, Mauro AC, et al. One hundred four of the 112 patients had a posterior procedure. Would you like email updates of new search results? McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. The medicolegal impact of misplaced pedicle and lateral mass screws on Quraishi NA, Hammett TC, Todd DB, et al. Spine (Phila Pa 1976). Neurological Outcome and Management of Pedicle Screws Misplaced Totally