When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. 2012 Feb 1;37(3):E188-94. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 2012;37(1):6776. Cookie Policy. 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%). J Neurosurg Spine. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 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. 2020;11:38. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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. Br J Neurosurg. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Luque ER: Segmental spinal instrumentation of lumbar spine. All the operations were done by one surgeon (PK). Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. While the majority of claims are found to lack merit, resulting in a verdict in favor of the defendant or case dismissal,7,1316 at least 37% are considered valid.26 Regardless, payouts to plaintiffs are often substantial, averaging in the hundreds of thousands to millions of dollars in both the US and Europe.10,11,14,17,20 Communication of errors and expectations, thorough documentation, and selection of appropriate patients and surgical indications have been shown to reduce the likelihood of a successful malpractice claim.13,16,27,28 In addition, attempts at tort reform in some states have helped limit the financial burden of medical malpractice payouts through methods such as capitation.16,20,22,26 However, efforts to limit malpractice claims in the first place are greatly needed. 2018;27(9):23392347. Results: A total of 2724 screws were placed in 127 patients. Neurosurgery. 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. National Library of Medicine 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. 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. to maintaining your privacy and will not share your personal information without 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Spine 8:970981, 1996. 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. 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). As compared to cases in 19952009, those in 20102019 resulted in a significantly higher average nominal payout to plaintiffs ($776,439 $74,460 vs $1,506,000 $385,527, p = 0.028). What can spine surgeons do to improve patient care and avoid medical negligence suits? Neurosurgery. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. 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. 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). 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. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Epub 2014 Jun 13. One hundred twelve patients were treated using the Cotrel-Dubousset pedicle screw fixation system for degenerative disease (57 patients), trauma (42 patients), infection (eight patients), and tumor (five patients) of the lumbar or thoracolumbar spine. 2018;43(14):984990. A p < 0.05 was considered statistically significant. JAMA Intern Med. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. 2013;123(9):20992103. Malpractice issues in neurological surgery. J Neurosurg Spine. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. 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. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 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. Epstein NE. Your current browser may not support copying via this button. J Bone Joint Surg 61A:201207, 1979. Spine (Phila Pa 1976). Under the high-low agreement, Drs. Quraishi NA, Hammett TC, Todd DB, et al. Percentage of cases per US region (center). Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 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. 2018;41(5):e615e620. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. J Neurosurg Spine. official website and that any information you provide is encrypted 2019;19(7):12211231. 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. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. $ = US$. J Bone Joint Surg 54A:11951204, 1972. Spine 13:952953, 1988. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. J Neurosurg. 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. Unauthorized use of these marks is strictly prohibited. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. 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). The rate of reoperation for screw misplacement per screw was 0.17%. Of note, the award amount for one settlement case was undisclosed. Lehmann TR, LaRocca HS: Repeat lumbar surgery: A review of patients with failure from previous lumbar surgery treated with spinal canal exploration and lumbar spine fusion. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. Clinical Orthopaedics and Related Research411:86-94, June 2003. 6. With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. 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 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. To reinforce spinal fixation, we have proposed a construct with segmental pedicle fixation two levels above and one level below the injured level and insertion of a screw deep into the pedicle, providing more contact area between screw head and bone and reducing the moment arm of the bending stress. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. Balch CM, Oreskovich MR, Dyrbye LN, et al. 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. Facebook Google Plus Youtube RSS Email. This site needs JavaScript to work properly. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. All Rights Reserved. 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. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Bethesda, MD 20894, Web Policies EOS System Courtesy of EOS imaging. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. 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. Disclaimer. 4. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 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. Spine 18:18621866, 1993. In four of these patients, bent screws occurred at 8 to 10 months after surgery; in three patients, broken screw necks were seen 1 year after surgery and in two patients, tulip screw plug dislodgments were observed at 4 and 6 months postoperatively, respectively. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. However, only a few complications were related to a poor clinical outcome. The patient had to undergo a subsequent surgery to remove the pedicles. Conclusion: 2014;75(6):609613. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). It has a great developing technique that is used for fixation and fusion in spine surgery. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Instead, the defense offered up an alternative explanation for Nyquists foot drop. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Pedicle screw insertion in the thoracolumbar spine. 8600 Rockville Pike 33. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. J Neurosurg Spine. This occurred on only one side and the correction achieved by the instrumentation was maintained. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. 5. Despite these failures, solid spinal arthrodesis was obtained in all patients. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Hardware-related failures were observed in 12 patients (10.7%). 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. 21. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. 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. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 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. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 2013;34(6):699705. Plaintiff-awarded cases by US region (left). To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Epub 2021 Aug 28. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Five patients had uneventful early postoperative course. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. 2014;96(4):266270. Lumbar Spine Surgery. 2012;7(6):e39237. 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. 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. Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature.
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