19. J Bone Joint Surg 45A:11591170, 1963. Bydon M, Xu R, Amin AG, et al. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. 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). Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Neurosurgery. J Neurosurg Spine. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. J Bone Joint Surg 61A:201207, 1979. 2018;83(5):9971006. Defensive medicine in U.S. spine neurosurgery. Spine 18:23252326, 1993. Rynecki ND, Coban D, Gantz O, et al. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Please enable it to take advantage of the complete set of features! Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. J Neurosurg Spine. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. 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. PMC 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. 33. Clin Orthop 227:1023, 1988. Eur Spine J. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. J Bone Joint Surg 62A:13021307, 1980. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. 0 attorneys agreed. 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. 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. HHS Vulnerability Disclosure, Help 3. 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. Elizabeth Hofheinz, M.P.H., M.Ed. Presse Med 78:14471448, 1970. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Epstein NE. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 5. 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. Med Econ. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Spine 18:983991, 1993. The intent is to provide relief from pain and nerve damage. However, the highest offer had been a combined $300,000 from the two defendants. However, the misplacement of pedicle screws can lead to disastrous complications. 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. MeSH Spine 19:25842589, 1994. From the *Department of Orthopaedic Surgery, University of Crete Medical School, Heraklion, Greece; and the **First Department of Orthopaedics, University of Athens Medical School, Athens, Greece. Methods. Clin Orthop 203:7598, 1986. Despite this problem, the clinical result was excellent. 2016;102(2):358362. The contact form sends information by non-encrypted email, which is not secure. The average age of the patients was 47 years and the average followup was 35 months. Spine J. 35. The amount awarded was not significantly different across US regions (p = 0.9; Fig. 27. All Rights Reserved. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. 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%). The https:// ensures that you are connecting to the 30. Accessibility Instead, the defense offered up an alternative explanation for Nyquists foot drop. 2011;365(7):629636. J Spine Surg. 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). Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. 14. Despite these failures, solid spinal arthrodesis was obtained in all patients. 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. 4. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. The link was not copied. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 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. 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. Please enable scripts and reload this page. Five patients had uneventful early postoperative course. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. J Pediatr Orthop. 10. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. 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. Clin Orthop 203:717, 1986. Analysis and interpretation of data: Sankey, TT Than. 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. Nottmeier EW, Seemer W, Young PM. 6 Operative information including fusion level, number of levels fused, level of misplaced screw(s), single versus multiple misplaced screw(s), presence of known CSF leakage, and primary injury due to screw misplacement was also collected. 2012;89(10):7071. Li HM, Zhang RJ, Shen CL. Copyright 2023 Becker's Healthcare. Spine J. Ann Thorac Surg. The rate of medical complications was 8%. EOS System Courtesy of EOS imaging. Hardware-related failures were observed in 12 patients (10.7%). With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 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. Am J Orthop. The patient had subsequent coronal imbalance and degeneration of the upper disc. These numbers are in line with the current literature. Call me tomorrow. 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. Svider PF, Husain Q, Kovalerchik O, et al. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. Would you like email updates of new search results? Materials and Methods Sixty . Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. Cookie Policy. Please try again soon. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). Fortunately, most of the complications were minor and transient. 2013;123(9):20992103. 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. 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. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. 2020;45(2):E111E119. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. A.J. 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. JAMA Intern Med. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. official website and that any information you provide is encrypted Wolters Kluwer Health
1. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. 2012;7(6):e39237. 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. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. 18. Rajasekaran S, Bhushan M, Aiyer S, et al. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 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 patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. J Bone Joint Surg 54A:11951204, 1972. J Neurosurg Spine. Reviewed submitted version of manuscript: all authors. Drs. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. 21. The screws were needed to stabilize the spine and fix the fused vertebrae in place. 2005;293(21):26092617. Potential complications may include increased pain, infection, or mechanical . 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. 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. Clin Orthop 284:8090, 1992. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. The plaintiff underwent revision surgery in May 2013. Moffatt-Bruce SD, Ferdinand FD, Fann JI. This site needs JavaScript to work properly. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). 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.