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. 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. All the operations were done by one surgeon (PK). 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. Arthrodesis was questionable in eight asymptomatic patients (7.1%). 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. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. 2017;27(4):470475. 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. Facebook Google Plus Youtube RSS Email. 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). All case demographics are summarized in Table 1. Methods. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. St Louis, CV Mosby 322327, 1987. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. 2002;27(22):24252430. 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. 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 ]. J Spine Surg. For more information, please refer to our Privacy Policy. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 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. J Bone Joint Surg 61A:201207, 1979. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Spine 13:10121018, 1988. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Svider PF, Husain Q, Kovalerchik O, et al. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Spine 6:615619, 1981. Call me tomorrow. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Unauthorized use of these marks is strictly prohibited. Defensive medicine in neurosurgery: the Canadian experience. 15. Friedlander and Bradley will pay half of the $2.25 million. 2013;123(9):20992103. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Malpractice risk according to physician specialty. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. 6. Clin Orthop 203:4553, 1986. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 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. 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. 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 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. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Sethi MK, Obremskey WT, Natividad H, et al. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Characteristics of medicolegal cases related to misplaced screws in spine surgery. A p < 0.05 was considered statistically significant. 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. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). Spine 17:349355, 1992. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. 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. This site needs JavaScript to work properly. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. 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. 2018;43(14):984990. The amount awarded was not significantly different across US regions (p = 0.9; Fig. 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. Spine (Phila Pa 1976). 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). 4. (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. However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. 28. 2020;162(6):13791387. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 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. Don't jump in get legal help. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Epstein NE. were excluded from analysis. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. Spine (Phila Pa 1976). Jena AB, Seabury S, Lakdawalla D, Chandra A. 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. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Rothberg MB, Class J, Bishop TF, et al. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. your express consent. 2012;21(suppl 2):S196S199. 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. Instead, the defense offered up an alternative explanation for Nyquists foot drop. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Dr. Abd-El-Barr is a consultant for Spineology. Of note, the award amount for one settlement case was undisclosed. 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. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. Segal J. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. may email you for journal alerts and information, but is committed
Review of neurosurgery medical professional liability claims in the United States. 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. Spine 18:11601172, 1993. 15. 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. 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. 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. doi: 10.1097/BPO.0000000000001828. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Hardware problems were those related to the physical change of metal and screw position. doi: 10.1097/BRS.0b013e31822a2e0a. J Neurosurg Spine. Spine 19(20 Suppl):2279S2296, 1994. Spine 17:834837, 1992. Personal consequences of malpractice lawsuits on American surgeons. In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. 2017;42(3):177185. 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. All Rights Reserved. Epub 2014 Apr 4. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Br J Neurosurg. Materials and Methods Sixty . However, the highest offer had been a combined $300,000 from the two defendants.
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