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. Rovit RL, Simon AS, Drew J, et al. Study design: 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. 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). The rate of reoperation for screw misplacement per screw was 0.17%. The patient had subsequent coronal imbalance and degeneration of the upper disc. 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. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. 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 ]. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. 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. Epstein NE. 2014;21(3):320328. Am J Otolaryngol. J Neurosurg. Of note, while only 38.2% (n = 26) of cases in our study mentioned the use of intraoperative radiographic confirmation, only one of these cases reported that the misplaced screw had been caught prior to leaving the operating room, which had resulted in an inadvertent dural tear and L5 nerve root injury. Spine (Phila Pa 1976). Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Please try again soon. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 38. 2013;123(9):20992103. * All the incidental dural tears were repaired immediately and produced no clinical sequelae. Some error has occurred while processing your request. Harrington PR, Tullos HS: Reduction of severe spondylolisthesis in children. 2. 2017;42(3):177185. your express consent. 2013;32(1):111119. 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. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. What can spine surgeons do to improve patient care and avoid medical negligence suits? Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Careers. Malpractice litigation following spine surgery. 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. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Spine (Phila Pa 1976). 6 A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. 2014;20(2):196203. 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. St Louis, CV Mosby 322327, 1987. 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. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. A total of 2724 screws were placed in 127 patients. 5-7 Materials and Methods This is a retrospective study of kyphotic spondylitis tuberculosis (Stb) patients conducted at Fatmawati General Hospital, Jakarta, Indonesia, through the year 2020-2021. Deyo RA, Mirza SK, Martin BI. 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. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. 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. 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. To prevent general complications, it is evident that precise and careful soft tissue handling, proper irrigation, and debridement during and after surgery, decrease of operative time, and proper patient monitoring postoperatively must be done. Critically revising the article: all authors. 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. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. 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. Each case was then carefully screened for relevance and sufficient data. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 2012;7(6):e39237. However, only a few complications were related to a poor clinical outcome. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 2014;20(6):636643. 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. 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. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 2013;34(6):699705. 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. 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. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Surg Neurol Int. An official website of the United States government. 13. J Bone Joint Surg 73A:11791184, 1991. 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. 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 However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. One hundred four of the 112 patients had a posterior procedure. Analysis and interpretation of data: Sankey, TT Than. 2016;102(2):358362. Despite this problem, the clinical result was excellent. 0 attorneys agreed. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 24. 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. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. This site needs JavaScript to work properly. Taylor CL. 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. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. All the operations were done by one surgeon (PK). Federal government websites often end in .gov or .mil. The third patient, who had central spinal stenosis, was treated by decompression alone. Malpractice liability and defensive medicine: a national survey of neurosurgeons. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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. Materials and Methods Sixty . Legal liability in iatrogenic orbital injury. 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. Spine 18:983991, 1993. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. Mason A, Paulsen R, Babuska JM, et al. 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. The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). 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. 20. Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Preparation. Five patients had uneventful early postoperative course. doi: 10.1097/BPO.0000000000001828. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. J Am Coll Surg. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 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. Drafting the article: Sankey. This occurred on only one side and the correction achieved by the instrumentation was maintained. Acquisition of data: Sankey. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 30. Ann Thorac Surg. Studdert DM, Mello MM, Sage WM, et al. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. 17. PLoS One. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. Level of evidence: Problems at the junctions of the instrumented spine were seen in five patients (4.5%). Conclusion: Neurosurgery. Sethi MK, Obremskey WT, Natividad H, et al. 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. 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. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. 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). official website and that any information you provide is encrypted Please enable scripts and reload this page. 7. 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. 2002;27(22):24252430. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Of note, the award amount for one settlement case was undisclosed. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. 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. 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. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. 11. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Spine 16(8 Suppl):S422427, 1991. Spine (Phila Pa 1976). 2009;10(1):3339. 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. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. (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. Spine 15:1114, 1990. Your current browser may not support copying via this button. Ahmadi SA, Sadat H, Scheufler KM, et al. Spine 14:472476, 1989. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Cookie Policy. 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. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. 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. and transmitted securely. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 2012;41(2):6973. 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. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. Spine 18:23252326, 1993. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Reviewed submitted version of manuscript: all authors. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Am J Transl Res. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. $ = US$. Clin Orthop 203:717, 1986. Despite these failures, solid spinal arthrodesis was obtained in all patients. 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 . Several limitations should be carefully considered when interpreting our results. Todd NV. Spine 15:908912, 1990. 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. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Spine (Phila Pa 1976). Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). In their meta-analysis of nine randomized controlled trials, Li et al. (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. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 32. 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. 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. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Seven hundred sixty-three screws were inserted in 138 patients. 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. 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. Results. 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. JAMA. Spine 18:18621866, 1993. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. 19. 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. 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). J Bone Joint Surg 61A:201207, 1979. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. 39. Administrative/technical/material support: Mehta, Wang, KD Than. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 5. 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. 8. Scarone P, Vincenzo G, Distefano D, et al. Dr. Abd-El-Barr is a consultant for Spineology. Potential complications may include increased pain, infection, or mechanical . 2014;96(4):266270. doi: 10.1097/BRS.0b013e31822a2e0a. 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.