J Neurosurg Spine. Reviewed submitted version of manuscript: all authors. Bethesda, MD 20894, Web Policies Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Clin Orthop 284:8090, 1992. 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. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 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. 2011;213(5):657667. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. The rate of medical complications was 8%. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. In their meta-analysis of nine randomized controlled trials, Li et al. 2014;75(6):609613. Malpractice claims in spine surgery in Germany: a 5-year analysis. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 20. The contact form sends information by non-encrypted email, which is not secure. 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). leg pain. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. Spine 17:349355, 1992. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) Of note, the award amount for one settlement case was undisclosed. 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. 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. Please enable it to take advantage of the complete set of features! Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Pedicle screw fixation is commonly used in spinal instrumentation surgeries to connect rods to vertebrae in order to correct spine alignment, stabilize vertebrae, and reach an arthrodesis. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. States were then grouped by US region and case year by 5-year intervals. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 2002;27(22):24252430. Scarone P, Vincenzo G, Distefano D, et al. 28. 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. Call me tomorrow. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. EOS System Courtesy of EOS imaging. These numbers are in line with the current literature. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. Conception and design: Sankey, KD Than. 9. Quraishi NA, Hammett TC, Todd DB, et al. 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. and 17.1% of the patients included had at least one screw misplaced. Smith TR, Hulou MM, Yan SC, et al. 29. 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). Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. 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. 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. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. Spine 18:11601172, 1993. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 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. A misplacement rate of more than 20 % (129 misplaced screws out of 608) seems to be unacceptable compared to only 4.5 % misplacements when using CT-navigation leading to the conclusion that pedicle screw instrumentation in the middle and upper thoracic area should be carried out with the help of navigation only. Nayar G, Blizzard DJ, Wang TY, et al. Fortunately, most of the complications were minor and transient. 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. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. J Spinal Disord Tech. official website and that any information you provide is encrypted Methods: HHS Vulnerability Disclosure, Help Spine J. 26. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Procedural errors led to combined payouts totaling $124,943,933 in neurosurgery claims between 2003 and 2012 in a study looking at data from the Physician Insurers Association of America Data Sharing Project.10 However, our study is the first to report the direct medicolegal impact of screw misplacement on US spine surgery, with 30.9% of judgments/settlements in favor of the plaintiff, resulting in average payouts of $1,204,422 $753,832 per claim. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 2016;102(2):358362. In the other patient, L4L5 float arthrodesis was done. Am J Otolaryngol. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Introduction. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Screw misplacement. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. The cost of defensive medicine on 3 hospital medicine services, Defensive medicine in neurosurgery: the Canadian experience, Review of neurosurgery medical professional liability claims in the United States, A nine-year review of medicolegal claims in neurosurgery, Malpractice risk according to physician specialty, Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003, Descriptive analysis of state and federal spine surgery malpractice litigation in the United States, Malpractice litigation following spine surgery, Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis, Malpractice claims in spine surgery in Germany: a 5-year analysis, On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim, Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England, Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort, It is easier to confuse a jury than convince a judge: the crisis in medical malpractice, Determining legal responsibility in otolaryngology: a review of 44 trials since 2008, Legal liability in iatrogenic orbital injury, Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study, Malpractice issues in neurological surgery. 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. 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The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Under the high-low agreement, Drs. 2014;174(11):18671868. 4. Spine 24:23522357, 1999. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. A total of 2396 screws were placed accurately (87.96%). Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. 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. Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Todd NV. Personal consequences of malpractice lawsuits on American surgeons. 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). Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Each side was judged separately. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Federal government websites often end in .gov or .mil. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Notwithstanding these concessions, the MDU argued that misplacement of pedicle screw tracts was common in surgery of this kind, even in experienced and competent hands. Linking and Reprinting Policy. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. A total of 69 patients (mean age, 67.416 . J Spine Surg. 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. Intraoperative pedicle fractures requiring further points of fixation. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. 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). The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. 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. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Level of evidence: Bydon M, Xu R, Amin AG, et al. Epub 2022 Oct 29. Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. 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. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 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. 38. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 19. J Neurosurg Spine. Results. PLoS One. Spine 18:18621866, 1993. Materials and Methods Sixty . Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. 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. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Bookshelf Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. National Library of Medicine 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. 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. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. 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. 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. Dr. Shaffrey has received grants from the NIH and Department of Defense. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. Pitfall: Unstable injuries. 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). Malpractice litigation following spine surgery. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). reporting that the number of Medicare patients who underwent a complex lumbar spine fusion for spinal stenosis increased 15-fold, from 1.3 persons per 100,000 Medicare persons in 2002 to 19.9 in 2007.31 Similarly, a study by Rajaee et al. 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. Clin Orthop 203:126134, 1986. Data is temporarily unavailable. However, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. Acta Neurochir (Wien). Statistical analysis: Sankey. 34. A p < 0.05 was considered statistically significant. Drafting the article: Sankey. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 2012;7(6):e39237. J Neurosurg Spine. 14. In patients with degenerative conditions, all of the affected segments were included in the instrumentation and each vertebra was fixed with two pedicle screws. Epub 2014 Jun 13. Li HM, Zhang RJ, Shen CL. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Legal liability in iatrogenic orbital injury. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. 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. Review of neurosurgery medical professional liability claims in the United States. Spine (Phila Pa 1976). Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Ann Thorac Surg. 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. 2012;37(1):6776. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 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. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Spine 13:10121018, 1988. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. + 48 696 042 504. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. J Neurosurg. * 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. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Careers. 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. The amount awarded was not significantly different across US regions (p = 0.9; Fig. N Engl J Med. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). However, the highest offer had been a combined $300,000 from the two defendants. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . Luque ER: Segmental spinal instrumentation of lumbar spine. 2,24,28,36. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Nahed BV, Babu MA, Smith TR, Heary RF.
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