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. St Louis, CV Mosby 322327, 1987. Spine 19(20 Suppl):2279S2296, 1994. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. The initial search using the terms above returned 3654 cases. 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 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. Daniels AH, Ruttiman R, Eltorai AEM, et al. 2018;29(4):397406. Through the use of expert witness testimony, Mr. da Costa was able to prove to the jury that by misplacing the pedicle screw during the surgery, and failing to timely diagnose and correct the malpositioned screw, Defendants deviated from accepted standards of care. 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. 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. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Nottmeier EW, Seemer W, Young PM. Would you like email updates of new search results? West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Fishers exact test and the Mann-Whitney U-test were used for the analysis of categorical and continuous data, respectively, except when an unpaired t-test was utilized for analyses related to normalized, nominal, and inflation-adjusted award totals. Can Postoperative Radiographs Accurately Identify Screw Misplacements? Seven hundred sixty-three screws were inserted in 138 patients. Study design: Statistical analysis: Sankey. 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. J Neurosurg Spine. Cookie Policy. Rovit RL, Simon AS, Drew J, et al. 2012;21(suppl 2):S196S199. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 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). 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Elizabeth Hofheinz, M.P.H., M.Ed. It has a great developing technique that is used for fixation and fusion in spine surgery. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. 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. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. FOIA Epub 2022 Oct 29. Int Orthop 20:3542, 1996. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. 8,24,25,32. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. 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? 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). Bookshelf Call me tomorrow. 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. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. A total of 2396 screws were placed accurately (87.96%). Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Laryngoscope. (%), Pseudarthrosis requiring revision surgery. This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. 2016;124(5):15241530. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Spine 18:11601172, 1993. 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. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). The accuracy of pedicle screw placement using intraoperative image guidance systems. 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. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Screw misplacement. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. 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. Rynecki ND, Coban D, Gantz O, et al. 2016;102(2):358362. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. What can spine surgeons do to improve patient care and avoid medical negligence suits? The average followup was 35 months (range, 1851 months). [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. 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. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Your current browser may not support copying via this button. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. 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. Defensive medicine in neurosurgery: the Canadian experience. Pedicle screw placement is a common procedure. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Fager CA. Spine 15:908912, 1990. 2021 Jul 1;41(Suppl 1):S80-S86. 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. 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. The rate of reoperation for screw misplacement per screw was 0.17%. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Spine (Phila Pa 1976). It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Spine 17:349355, 1992. Epstein NE. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Methods: 3). Clipboard, Search History, and several other advanced features are temporarily unavailable. Results: A total of 2724 screws were placed in 127 patients. may email you for journal alerts and information, but is committed
Summary of background data: 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. Objective: 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. Copyright 2023 Becker's Healthcare. Bydon M, Xu R, Amin AG, et al. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Todd NV. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). 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. Spine 16:576579, 1991. The average age of the patients was 47 years and the average followup was 35 months. 4. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). J Bone Joint Surg 45A:11591170, 1963. 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. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. JAMA. Am J Orthop. 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. Acta Neurochir (Wien). 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. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. However, the misplacement of pedicle screws can lead to disastrous complications. Spine 13:696706, 1988. 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. 6 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. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. In the other patient, L4L5 float arthrodesis was done. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Nationally Recognized Regionally Dominant Contact Us Now For a Free Consultation Over $850 Million in Verdicts and Settlements Home Articles Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction South Med J 62:17, 1969. Reviewed submitted version of manuscript: all authors. 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 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). government site. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, 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, 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, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, 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, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. The third patient, who had central spinal stenosis, was treated by decompression alone. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. J Bone Joint Surg 54A:11951204, 1972. matte black square deadbolt; roberts point park fishing report; qr code on binax covid test; mff premium character list. 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. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Ahmadi SA, Sadat H, Scheufler KM, et al. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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. 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. Guillain A, Moncany AH, Hamel O, et al. MeSH 2. Drafting the article: Sankey. 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. Malpractice risk according to physician specialty. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 2013;34(6):699705. Please try after some time. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 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). 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. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. 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. 3. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Epub 2021 Aug 28. 2017;42(3):177185. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Presse Med 78:14471448, 1970. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. pedicle screw misplacement malpractice. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. 2. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. 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. official website and that any information you provide is encrypted Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Malpractice litigation following spine surgery. Br J Neurosurg. Careers. Thu, May 27th, 2021. 2011;213(5):657667. sharing sensitive information, make sure youre on a federal 8600 Rockville Pike There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). The link was not copied. J Pediatr Orthop. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. The medicolegal landscape of spine surgery: how do surgeons fare? Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Each side was judged separately. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 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. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Fortunately, most of the complications were minor and transient. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. 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. 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.