pedicle screw misplacement malpractice

One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. South Med J 62:17, 1969. J Pediatr Orthop. Hardware problems were those related to the physical change of metal and screw position. Each side was judged separately. 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. 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. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 32. 3). Reviewed submitted version of manuscript: all authors. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. Categorical and continuous data are described as frequency (percentage) and median (interquartile range), respectively, except for the use of mean standard deviation for award amounts since both nominal and inflation-adjusted award totals passed (alpha = 0.05) the DAgostino-Pearson omnibus normality test. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Please try again soon. Neurological outcome and management of pedicle screws - PubMed All Rights Reserved. Spine (Phila Pa 1976). Neurological Outcome and Management of Pedicle Screws Misplaced Totally 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. to maintaining your privacy and will not share your personal information without The pedicle screws judged as misplacement. a Medial minor perforation 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. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. Orthop Trans 11:99, 1987. Level of evidence: Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 4. Screw misplacement. Quraishi NA, Hammett TC, Todd DB, et al. Defensive medicine in neurosurgery: the Canadian experience. Epub 2021 Aug 28. Luque ER: Segmental spinal instrumentation of lumbar spine. J Neurosurg Spine. Sethi MK, Obremskey WT, Natividad H, et al. Spine 17:349355, 1992. Lawsuit information regarding the plaintiffs age at the time of the malpractice claim, sex, postoperative complaint, indication for index surgery, defendant surgeon specialty (neurosurgery vs orthopedics), and delayed diagnosis or treatment, as well as case location by state and case year, was obtained. Copyright 2023 Becker's Healthcare. 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. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. The average age of the patients was 47 years and the average followup was 35 months. Image intensification and the technique recommended by Weinstein et al 32 was used for screw placement in the lumbar vertebrae, whereas Chopin blocks (Medtronic Sofamor Danek) with two screws diverging bilaterally were used for sacral fixation. The initial search using the terms above returned 3654 cases. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. The cost of defensive medicine on 3 hospital medicine services. Surg Neurol Int. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 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. PDF Intraoperative biomechanics of lumbar pedicle screw loosening following Taylor CL. Bydon M, Xu R, Amin AG, et al. 0 attorneys agreed. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. 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. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. 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. 2012;7(6):e39237. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Todd NV. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Spine 13:10121018, 1988. shooting in valdosta leaves one dead Clin Orthop 203:717, 1986. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. 2012 Feb 1;37(3):E188-94. Despite this problem, the clinical result was excellent. doi: 10.1097/BRS.0b013e31822a2e0a. 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. Percentage of cases per US region (center). The plaintiff received $2.4 million for pain and suffering and loss of enjoyment of life, $2 million for lost income and approximately $123,000 for medical expenses. J Neurosurg Spine. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed et al. Some error has occurred while processing your request. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. 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. 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. The https:// ensures that you are connecting to the 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. 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. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 2013;123(9):20992103. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. 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Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Presse Med 78:14471448, 1970. Defensive medicine: a culprit in spiking healthcare costs. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Clin Orthop 203:126134, 1986. Routine CT scans were taken in all patients. J Am Coll Surg. 2018;83(5):9971006. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Conception and design: Sankey, KD Than. 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. 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. Nahed BV, Babu MA, Smith TR, Heary RF. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Please enable scripts and reload this page. Objective: 29. Malpractice issues in neurological surgery. Careers. Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in Zaleski v Elmhurst Eye Surgery Center. Thoracic pedicle screw placement: Free-hand technique - Bioline Rajasekaran S, Bhushan M, Aiyer S, et al. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Epub 2014 Jun 13. 14. This occurred on only one side and the correction achieved by the instrumentation was maintained. A total of 69 patients (mean age, 67.416 . In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). However, the misplacement of pedicle screws can lead to disastrous complications. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. J Bone Joint Surg 45A:11591170, 1963. Pedicle screw insertion - AO Foundation Unauthorized use of these marks is strictly prohibited. Acquisition of data: Sankey. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). 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%. J Neurosurg Spine. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 2. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. (PDF) Accuracy of pedicle screw placement in the lumbosacral spine The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Malpractice risk according to physician specialty. 15. 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). J Bone Joint Surg 62A:13021307, 1980. Pedicle screw | definition of pedicle screw by Medical dictionary CT-navigation versus fluoroscopy-guided placement of pedicle screws at Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. $ = US$. 2005;293(21):26092617. National Library of Medicine Before 36. Linking and Reprinting Policy. In White AH, Rothman RH, Ray CD (eds). All the operations were done by one surgeon (PK). Spine Deform. 5. One hundred twelve patients were treated using the Cotrel-Dubousset pedicle screw fixation system for degenerative disease (57 patients), trauma (42 patients), infection (eight patients), and tumor (five patients) of the lumbar or thoracolumbar spine. A rod is used to hold the vertebra together to allow fusion to occur. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 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. 1. Laryngoscope. The average followup was 35 months (range, 1851 months). Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Neurosurgical practice liability: relative risk by procedure type. Robotic-assisted pedicle screw placement fails to reduce overall Epstein NE. 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. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Results: 2011;213(5):657667. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Methods: As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. laterally placed screws and the azygous vein on the right (T5-T11). 34. Orthopedics. J Bone Joint Surg 54A:11951204, 1972. 2018;41(5):e615e620. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. Open lumbar pedicle screw technique - Operative Neurosurgery Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Both of these patients complained of thigh pain but refused any additional surgery. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Summary of background data: Eur Spine J. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. 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. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect 2006;65(4):416421. 2014;20(6):636643. 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. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? A total of 2396 screws were placed accurately (87.96%). 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. You may be trying to access this site from a secured browser on the server. 2020;11:38. Analysis and interpretation of data: Sankey, TT Than. Are We Underestimating the Significance of Pedicle Screw Misplacement Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. 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. Br J Neurosurg. 21. 2,24,28,36. Your message has been successfully sent to your colleague. Federal government websites often end in .gov or .mil. Please try after some time. 2012;41(2):6973. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. J Bone Joint Surg 73A:11791184, 1991. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA.

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