Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws.
Are We Underestimating the Significance of Pedicle Screw Misplacement Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Instead, the defense offered up an alternative explanation for Nyquists foot drop. J Am Coll Surg. Median screw misplacement rate was 10% in group A and 13% in group B.
and 17.1% of the patients included had at least one screw misplaced. You are talking one of the most complicated area of the law. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Materials and Methods Sixty . The medicolegal landscape of spine surgery: how do surgeons fare? Dr. Shaffrey has received grants from the NIH and Department of Defense. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. None of these complications resulted in additional surgery or in a significant increase of morbidity. 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. 2014;20(6):636643. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Federal government websites often end in .gov or .mil. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. 14. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. 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 screw insertion - AO Foundation 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. Data is temporarily unavailable. Spine 13:696706, 1988. Sethi MK, Obremskey WT, Natividad H, et al. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Spine 16(8 Suppl):S455458, 1991. 10.
True accuracy of percutaneous pedicle screw placement in thoracic and 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. (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. 17. States were then grouped by US region and case year by 5-year intervals. Epub 2022 Oct 29.
Robotic-assisted pedicle screw placement fails to reduce overall One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. 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. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Neurosurgery. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. A total of 69 patients (mean age, 67.416 . This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Spine 15:1114, 1990. J Neurosurg. However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). 3. Malpractice litigation following spine surgery. 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. 34. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 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. 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. The accuracy of pedicle screw placement using intraoperative image guidance systems. 28. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 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. doi: 10.1097/BRS.0b013e31822a2e0a. 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. Spine 15:908912, 1990. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. These numbers are in line with the current literature. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Potential complications may include increased pain, infection, or mechanical . 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. 20. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Several limitations should be carefully considered when interpreting our results. 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. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. All Rights Reserved. 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. 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. Results: A total of 2724 screws were placed in 127 patients. Surg Neurol.
Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 South Med J 62:17, 1969. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Spine 6:615619, 1981. 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. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. 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. This site needs JavaScript to work properly. 21. Spine 16:576579, 1991. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Epub 2014 Apr 4. Orthopedics. 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. Epstein NE. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. 9. 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.
Pedicle Screw Malposition Expert Witness: Malposition Can Lead to Review of neurosurgery medical professional liability claims in the United States. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Neurologic injury. Methods. Spine (Phila Pa 1976). J Neurosurg Spine. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Defensive medicine in U.S. spine neurosurgery. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. This patient recovered completely in 6 weeks. 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. 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. Hardware problems were those related to the physical change of metal and screw position. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Spine 17:349355, 1992. 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. 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 accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Rajasekaran S, Bhushan M, Aiyer S, et al. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Jena AB, Seabury S, Lakdawalla D, Chandra A. Despite this problem, the clinical result was excellent. Routine CT scans were taken in all patients. J Neurosurg Spine. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. MeSH Forty-seven general complications were seen in 41 patients (36.5%). However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. 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. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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). 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. And while the offending screw was removed the next day, Nyquist continued to experience right foot drop, along with lower back pain and sciatica, i.e. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. 2016;102(2):358362. 27. 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. 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). The patient suffered permanent nerve damage as a result of the puncture. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. to maintaining your privacy and will not share your personal information without
Plaintiff-awarded cases by US region (left). 29. 11.
Partner, Paul M. da Costa, Obtains $4.5 Million Verdict - Snyder Sarno The .gov means its official. All Rights Reserved. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). In the other patient, L4L5 float arthrodesis was done. 2017;31(3):287288. 26. A total of 2724 screws were placed in 127 patients. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. leg pain. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 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. Summary of background data: 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. 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. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. A total of 2396 screws were placed accurately (87.96%). In their meta-analysis of nine randomized controlled trials, Li et al. Clin Orthop 203:7598, 1986. Surg Neurol Int. 2011;306(10):1088. 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 Balch CM, Oreskovich MR, Dyrbye LN, et al. * laterally placed screws and the azygous vein on the right (T5-T11). The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). $ = US$. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. Med Econ. HHS Vulnerability Disclosure, Help 2. 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. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. Dr. Abd-El-Barr is a consultant for Spineology. Accessibility
Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR I won't be at the office but I will check my voice mail. 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. In the current study, no incidence of bent and broken screws or tulip screw plug dislodgement necessitated additional treatment, and all the patients achieved solid fusion despite the failure of instrumentation. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Spine (Phila Pa 1976). 12. Svider PF, Husain Q, Kovalerchik O, et al. The screws were needed to stabilize the spine and fix the fused vertebrae in place. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Elizabeth Hofheinz, M.P.H., M.Ed. 0 attorneys agreed. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al.
Neurological Outcome and Management of Pedicle Screws Misplaced Totally 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. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Taylor CL. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 2,24,28,36. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Level of evidence: 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. A p < 0.05 was considered statistically significant. Spine J. All the operations were done by one surgeon (PK). Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Of note, the award amount for one settlement case was undisclosed. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software).
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