2018;43(14):984990. Spine 19(20 Suppl):2279S2296, 1994. Clipboard, Search History, and several other advanced features are temporarily unavailable. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 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. 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. All the operations were done by one surgeon (PK). This site needs JavaScript to work properly. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. 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. 2002;27(22):24252430. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Br J Neurosurg. While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Daniels AH, Ruttiman R, Eltorai AEM, et al. Show more. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 2012;7(6):e39237. Dr. Abd-El-Barr is a consultant for Spineology. 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. 11. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 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 13:696706, 1988. The medicolegal landscape of spine surgery: how do surgeons fare? Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. 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. 2020;11:38. J Neurosurg Spine. and transmitted securely. 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. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. J Neurosurg Spine. 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. 4). 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. 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. J Bone Joint Surg 73A:11791184, 1991. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 2017;27(4):470475. 2017 Mar;5(2):109-116. doi: 10.1016/j.jspd.2016.10.007. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. One hundred four of the 112 patients had a posterior procedure. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Each case was then carefully screened for relevance and sufficient data. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. . Your message has been successfully sent to your colleague. Accessibility 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. Linking and Reprinting Policy. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 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%). 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. 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. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Reviewed submitted version of manuscript: all authors. 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. 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). Pullout performance comparison of pedicle screws based on cement application and design parameters Tolga Tolunay, Cemile Bagl, Teyfik Demir, Mesut E Yaman, and Arslan K Arslan Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2015 229: 11 , 786-793 Download Citation Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 23. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Objective: The initial search using the terms above returned 3654 cases. Spine J. 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. The rate of reoperation for screw misplacement per screw was 0.17%. Spine J. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. 2. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Insuring spinal neurosurgery. Don't jump in get legal help. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Am J Orthop. 2016;102(2):358362. 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. 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. 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. A.J. 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. Clinical Orthopaedics and Related Research411:86-94, June 2003. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. You are talking one of the most complicated area of the law. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. 2017;31(3):287288. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. JAMA. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. Acta Neurochir (Wien). The link was not copied. Conclusion: Spine 13:10121018, 1988. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 patients. 2011;365(7):629636. 4. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 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. J Neurosurg Spine. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. 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). Neurologic injury. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. The third patient, who had central spinal stenosis, was treated by decompression alone. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. 2018;41(5):e615e620. Spine 16:576579, 1991. were excluded from analysis. Surg Neurol. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 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.
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