Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 3. 27. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. Screw misplacement. Spine 17:349355, 1992. Spine 13:696706, 1988. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Epub 2014 Jun 13. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Over 40% of patients had screws with either some/major concern. Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. 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. 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. In their meta-analysis of nine randomized controlled trials, Li et al. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Defendant-awarded cases by US region (right). However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 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. Surg Neurol. Spine 14:472476, 1989. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. The patient had subsequent coronal imbalance and degeneration of the upper disc. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 2011;365(7):629636. 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. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Eur Spine J. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Studdert DM, Mello MM, Sage WM, et al. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. doi: 10.1097/BRS.0b013e31822a2e0a. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. 4. 1. Br J Neurosurg. 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. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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). Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. 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. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 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. PMC Cerebrospinal fluid fistulas. Facebook Google Plus Youtube RSS Email. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Unable to load your collection due to an error, Unable to load your delegates due to an error. 3. J Bone Joint Surg 73A:11791184, 1991. $ = US$. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 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). However, only a few complications were related to a poor clinical outcome. Please enable scripts and reload this page. Clin Orthop 203:717, 1986. 19. You may be trying to access this site from a secured browser on the server. Don't jump in get legal help. J Neurosurg Spine. Malpractice litigation following spine surgery. Med Econ. (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. + 48 696 042 504. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. Agarwal N, Gupta R, Agarwal P, et al. 21. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 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. In the current study, only five patients with junction problems above the instrumented area were observed with the following probable predisposing factors: an already degenerative disc, coronal imbalance, very long arthrodesis, and old age. Dr. Abd-El-Barr is a consultant for Spineology. 2002;27(22):24252430. Copyright © 2023 Becker's Healthcare. Methods. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. 25. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). 2018;28(2):186193. 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. 6 Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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. Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. 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. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. 2019;19(7):12211231. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 2,24,28,36. 35. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . The rate of reoperation for screw misplacement per screw was 0.17%. The patient had to undergo a subsequent surgery to remove the pedicles. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. 2. 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. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Presse Med 78:14471448, 1970. Conclusion: leg pain. Spine (Phila Pa 1976). Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Nyquist followed a medical malpractice lawsuit against Dr. Masnyk for his surgical error, alleging that the surgeon had improperly positioned the right L4 pedicel screw which had resulted in a nerve root injury and Nyquists subsequent foot drop. 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. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. 2018;18(2):209215. 2013;32(1):111119. Level of evidence: Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Moffatt-Bruce SD, Ferdinand FD, Fann JI. 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. Spine 18:18621866, 1993. 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. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. The https:// ensures that you are connecting to the 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. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . All case demographics are summarized in Table 1. Pitfall: Unstable injuries. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . All Rights Reserved. 2017;27(4):470475. Epub 2014 Apr 4. I won't be at the office but I will check my voice mail. 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. 2014;21(3):320328. 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. Hecht N, Kamphuis M, Czabanka M, et al. Epstein NE. Guillain A, Moncany AH, Hamel O, et al. 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. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. Clipboard, Search History, and several other advanced features are temporarily unavailable. Weinstein JN, Spratt KF, Spengler D, Brick C, Reid S: Spinal pedicle fixation: Reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement. However, the misplacement of pedicle screws can lead to disastrous complications. Deyo RA, Mirza SK, Martin BI. 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. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 2. . 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. 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. Bethesda, MD 20894, Web Policies 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. 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. Spine (Phila Pa 1976). your express consent. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 2006;65(4):416421. Median screw misplacement rate was 10% in group A and 13% in group B. However, the misplacement of pedicle screws can lead to disastrous complications. (%), Pseudarthrosis requiring revision surgery. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Eur Spine J. Preparation. Materials and Methods Sixty . Personal consequences of malpractice lawsuits on American surgeons. Objective: Svider PF, Kovalerchik O, Mauro AC, et al. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Spine 24:23522357, 1999. The patient suffered permanent nerve damage as a result of the puncture. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. 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. Friedlander and Bradley will pay half of the $2.25 million. Svider PF, Husain Q, Kovalerchik O, et al. and 17.1% of the patients included had at least one screw misplaced. Todd NV. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. 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. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. J Bone Joint Surg 62A:13021307, 1980. 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). 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 ]. Please try again soon. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. The cost of defensive medicine on 3 hospital medicine services. 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. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 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. Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. J Neurosurg Spine. Despite these failures, solid spinal arthrodesis was obtained in all patients. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Luque ER: Segmental spinal instrumentation of lumbar spine. Epub 2022 Oct 29. Orthop Trans 11:99, 1987. 2014;20(2):196203. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. 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. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Insuring spinal neurosurgery. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. The plaintiff underwent revision surgery in May 2013. Li HM, Zhang RJ, Shen CL. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). 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. 24. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. 2012;89(10):7071. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Five patients had uneventful early postoperative course. Daniels AH, Ruttiman R, Eltorai AEM, et al. 22. Drafting the article: Sankey. Forty-seven general complications were seen in 41 patients (36.5%). Each side was judged separately. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Neurosurgical practice liability: relative risk by procedure type. Sethi MK, Obremskey WT, Natividad H, et al. Privacy Policy. Bookshelf Epstein NE. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. The intent is to provide relief from pain and nerve damage. 5. 2012 Feb 1;37(3):E188-94. Per-patient analysis reveals more concerning numbers toward screw misplacement. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. * Descriptive analysis of state and federal spine surgery malpractice litigation in the United States.
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