Spine 6:263267, 1981. NCI CPTC Antibody Characterization Program. 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. 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. Please enable scripts and reload this page. 17. The patient had subsequent coronal imbalance and degeneration of the upper disc. 2017;27(4):470475. What can spine surgeons do to improve patient care and avoid medical negligence suits? 4. The average age of the patients was 47 years and the average followup was 35 months. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. Intraoperative pedicle fractures requiring further points of fixation. The site is secure. 2016;124(5):15241530. Wolters Kluwer Health
Malpractice risk according to physician specialty. 24. Smith TR, Hulou MM, Yan SC, et al. Despite these failures, solid spinal arthrodesis was obtained in all patients. Am J Transl Res. shooting in valdosta leaves one dead Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 Thu, May 27th, 2021. Defensive medicine in neurosurgery: the Canadian experience. A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. J Neurosurg Spine. 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. 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. In White AH, Rothman RH, Ray CD (eds). Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Nahed BV, Babu MA, Smith TR, Heary RF. 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. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 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. J Neurosurg Spine. $ = US$. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. 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. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Presse Med 78:14471448, 1970. Of note, the award amount for one settlement case was undisclosed. Author links open overlay panel Mohamad Bydon a b 1, Dimitrios Mathios a b 1, Mohamed Macki a b, Rafael De la Garza-Ramos a b, Nafi Aygun c, Daniel M. Sciubba a, Timothy F. Witham a, Ziya L. Gokaslan a b, Ali Bydon a b, Jean-Paul Wolinksy a. Spine 15:1114, 1990. 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. Makhni MC, Park PJ, Jimenez J, et al. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 3). 6 Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. 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. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 2012;7(6):e39237. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Orthopedics. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Median screw misplacement rate was 10% in group A and 13% in group B. 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. doi: 10.1097/BRS.0b013e31822a2e0a. 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. Linking and Reprinting Policy. Bydon M, Xu R, Amin AG, et al. 1. National Library of Medicine Spine J. 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. 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. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. 2011;213(5):657667. Thoracic Pedicle Screws - ScienceDirect 2022 Sep 15;14(9):6323-6331. eCollection 2022. None of these complications resulted in additional surgery or in a significant increase of morbidity. . 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 Orthop Trans 11:99, 1987. Conclusion: 10. Balch CM, Oreskovich MR, Dyrbye LN, et al. 2014;174(11):18671868. 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. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Pedicle screw accuracy in thoracolumbar fractures- is routine Eur Spine J. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt MeSH 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). Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. The initial search using the terms above returned 3654 cases. 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. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). 2016;25(3):716723. We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. official website and that any information you provide is encrypted Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). J Spine Surg. In their meta-analysis of nine randomized controlled trials, Li et al. 19. However, only a few complications were related to a poor clinical outcome. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. I won't be at the office but I will check my voice mail. 2018;28(2):186193. Rothberg MB, Class J, Bishop TF, et al. A total of 2724 screws were placed in 127 patients. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. Spine (Phila Pa 1976). Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. 2011;306(10):1088. 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. (%), Pseudarthrosis requiring revision surgery. Analysis and interpretation of data: Sankey, TT Than. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). Pitfall: Unstable injuries. 28. Epstein NE. Clin Orthop 203:4553, 1986. Din RS, Yan SC, Cote DJ, et al. 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. 2. Level of evidence: Patient-specific 3D-printed surgical guides for pedicle screw insertion 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. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. The plaintiff underwent revision surgery in May 2013. The radiology results showed that the surgical screw placed at the right L4-5 area had breached the medial wall and was actually extending into the spinal canal. Neurological outcome and management of pedicle screws - PubMed 32. 2002;27(22):24252430. Spine 18:983991, 1993. 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. 3. Health Aff (Millwood). An official website of the United States government. 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. 26. 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. This site needs JavaScript to work properly. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. J Neurosurg Spine. 11. Cookie Policy. 23. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. All Rights Reserved. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. Potential complications may include increased pain, infection, or mechanical . A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Patient safety: disclosure of medical errors and risk mitigation. 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. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. 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. single homes for sale in lehigh valley, pa Spine 17:834837, 1992. 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). You may be trying to access this site from a secured browser on the server. Complications and Problems Related to Pedicle Screw Fixation - LWW (PDF) Accuracy of pedicle screw placement in the lumbosacral spine Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Forty-seven general complications were seen in 41 patients (36.5%). Accuracy of C2 pedicle screw placement using the anatomic freehand 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. The screws were needed to stabilize the spine and fix the fused vertebrae in place. 2018;43(14):984990. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. 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. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. 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. For more information, please refer to our Privacy Policy. 15. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Your message has been successfully sent to your colleague. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. J Neurosurg Spine. 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. 3. 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. Studdert DM, Mello MM, Sage WM, et al. Characteristics of medicolegal cases related to misplaced screws in spine surgery. 2011;365(7):629636. Defensive medicine: a culprit in spiking healthcare costs. Privacy Policy. 5. 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. 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. The rate of reoperation for screw misplacement per screw was 0.17%. Review of neurosurgery medical professional liability claims in the United States. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) The accuracy of pedicle screw placement using intraoperative image guidance systems. States were then grouped by US region and case year by 5-year intervals. 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. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. 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. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 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. 9. Todd NV. Spine 6:615619, 1981. 31. 2014;96(4):266270. South Med J 62:17, 1969. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. 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. Spine 13:10121018, 1988. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). J Am Coll Surg. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. 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. 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. Acta Neurochir (Wien). Spine 16:576579, 1991. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Administrative/technical/material support: Mehta, Wang, KD Than. Spine 18:18621866, 1993. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Bethesda, MD 20894, Web Policies Spine 15:908912, 1990. Lumbar Spine Surgery. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Hecht N, Kamphuis M, Czabanka M, et al. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Epub 2014 Apr 4. 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. Both of these patients complained of thigh pain but refused any additional surgery.
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