2006;65(4):416421. Under the high-low agreement, Drs. 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 ]. Methods. Don't jump in get legal help. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Drafting the article: Sankey. Please enable scripts and reload this page. 2. Review of neurosurgery medical professional liability claims in the United States. J Neurosurg. 3. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. 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. Objective: Methods: [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. What can spine surgeons do to improve patient care and avoid medical negligence suits? 20. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. The link was not copied. Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). 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. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Unable to load your collection due to an error, Unable to load your delegates due to an error. Linking and Reprinting Policy. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Br J Neurosurg. Copyright © 2023 Becker's Healthcare. Cerebrospinal fluid fistulas. Reviewed submitted version of manuscript: all authors. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. Epub 2014 Apr 4. 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. All Rights Reserved. J Am Coll Surg. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. 5. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. The site is secure. Spine 13:952953, 1988. Partner, Paul M. da Costa, Obtains $4.5 Million Verdict - Snyder Sarno The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. Patient-specific 3D-printed surgical guides for pedicle screw insertion Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Wolters Kluwer Health One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. PLoS One. 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. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. 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. 2012;21(suppl 2):S196S199. Dr. Abd-El-Barr is a consultant for Spineology. 4). Critically revising the article: all authors. Dr. Abd-El-Barr is a consultant for Spineology. Drs. 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. FOIA A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Malpractice claims in spine surgery in Germany: a 5-year analysis. Clin Orthop 227:1023, 1988. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Bydon M, Xu R, Amin AG, et al. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following Neurological outcome and management of pedicle screws - PubMed Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Analysis and interpretation of data: Sankey, TT Than. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. 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? Agarwal N, Gupta R, Agarwal P, et al. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. However, the misplacement of pedicle screws can lead to disastrous complications. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. 13. 31. 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. 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. 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. 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. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 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. 9. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 5. government site. A neurologic deficit developed in one patient (0.9%) who had partial bilateral drop feet after reduction of L4L5 spondylolisthesis. Thu, May 27th, 2021. Quraishi NA, Hammett TC, Todd DB, et al. 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 In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. 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. Eur Spine J. 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. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Pedicle screw placement: Robotic assistance for greater precision Int Orthop 20:3542, 1996. The medicolegal landscape of spine surgery: how do surgeons fare? 19. Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. J Bone Joint Surg 62A:13021307, 1980. Defensive medicine: a culprit in spiking healthcare costs. 2011;213(5):657667. 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. 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, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. 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. Friedlander and Bradley will pay half of the $2.25 million. 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. demonstrated that the number of hospital discharges for spinal fusion increased 2.4 times (137%) from 174,223 to 413,171 (p < 0.001) between 1998 and 2008.32 The true frequency of malpositioned pedicle and lateral mass screws is likely underestimated in spine surgery given the fact that the majority of misplaced screws, as well as the potential complications related to them, are not reported in practice and may be clinically silent. 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. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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. Intraoperative pedicle fractures requiring further points of fixation. 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). Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 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. 2014;20(2):196203. Privacy Policy. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Spine 18:983991, 1993. 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. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Delayed open treatment of aortic penetration by a thoracic pedicle SECTION I SYMPOSIUM: Advances in Spine Surgery, Distribution of Spinal Disorders in 112 Patients, Classification of Complications in 64 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. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 2011;306(10):1088. 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. 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. Am J Transl Res. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. Spine 19(20 Suppl):2279S2296, 1994. Level of evidence: The average followup was 35 months (range, 1851 months). your express consent. 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.