Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. 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. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort. Administrative/technical/material support: Mehta, Wang, KD Than. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). For more information, please refer to our Privacy Policy. 2019;19(7):12211231. 2021 Jul 1;41(Suppl 1):S80-S86. We serve the following localities: Cook County including Arlington Heights, Barrington, Berwyn Township, Chicago, Des Plaines, Glenview, Orland Park, Palos Park, Schaumburg, and Tinley Park; DuPage County including Downers Grove, Naperville, and Bolingbrook; Kane County including Aurora, Elgin and Geneva; Lake County including Waukegan; and Will County including Joliet. 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. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). 31. 2014;174(11):18671868. J Bone Joint Surg 62A:13021307, 1980. 2013;34(6):699705. Spine 18:23252326, 1993. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 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. Spine J. Spine 19:25842589, 1994. 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. laterally placed screws and the azygous vein on the right (T5-T11). Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. Ann R Coll Surg Engl. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. The third patient, who had central spinal stenosis, was treated by decompression alone. Potential complications may include increased pain, infection, or mechanical . 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. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Spine 16(8 Suppl):S455458, 1991. 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). Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Epub 2014 Jun 13. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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. Spine (Phila Pa 1976). Epstein NE. J Bone Joint Surg 54A:11951204, 1972. Pedicle screw insertion - AO Foundation This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. J Bone Joint Surg 61A:201207, 1979. Of note, the award amount for one settlement case was undisclosed. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. The contact form sends information by non-encrypted email, which is not secure. It has a great developing technique that is used for fixation and fusion in spine surgery. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. However, only a few complications were related to a poor clinical outcome. official website and that any information you provide is encrypted Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. Re: malpositioned pedicle screw resulting in additional surgery and disability. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Review of neurosurgery medical professional liability claims in the United States. Presse Med 78:14471448, 1970. 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. 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. The highly litigious environment within healthcare has resulted in a majority of physicians practicing defensive medicine,15 often leading to burnout6,7 and an exorbitant ethical and financial burden on medical and surgical care.7,8 In 2008, medical liability accounted for $55.6 billion, representing 2.4% of the United States (US) healthcare expenditures that year,5,7,9,10 and the pervasive practice of defensive medicine may cost up to $210 billion annually in the US.5 A similar trend has been observed in Europe.11, Neurosurgery is the specialty most frequently affected by lawsuits and the fear of litigation, both in the US and abroad,12 with spine surgery at the forefront.11,1317 As a result, spine surgeons are nearly three times more likely than nonspine surgeons to practice defensive medicine, defined as the avoidance of high-risk procedures and the provision of unnecessary services and assessments beyond what is clinically necessary in an effort to avoid litagation.5 The average time to judgment in a case is approximately 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 As a result, physicians spend an average of 11% of their careers dealing with one or more open malpractice claims.18 Neurosurgeons are especially impacted, spending an average of 27.2% of their careers in an open lawsuit.10. 3. 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. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Statistical analysis: Sankey. Rothberg MB, Class J, Bishop TF, et al. Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar J Neurosurg Spine. Thu, May 27th, 2021. The medicolegal landscape of spine surgery: how do surgeons fare? Summary of background data: L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. These numbers are in line with the current literature. Neurologic injury. 2. Rovit RL, Simon AS, Drew J, et al. South Med J 62:17, 1969. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. J Am Coll Surg. A.J. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 5. 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. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. $2 Million Spinal Surgery Case Against Neurosurgeon and Hospital 27. Clin Orthop 203:7598, 1986. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. 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. 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. Spine (Phila Pa 1976). A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Scarone P, Vincenzo G, Distefano D, et al. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . Spine 6:263267, 1981. A total of 2396 screws were placed accurately (87.96%). Spine 13:10121018, 1988. However, the misplacement of pedicle screws can lead to disastrous complications. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. Clin Orthop 227:1023, 1988. 22. The patient had to undergo a subsequent surgery to remove the pedicles. 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). Judgment information associated with a defendant (surgeon) versus plaintiff (patient) ruling, trial versus settlement versus arbitration decision, award amount, and time to decision or case closure from index surgery was also recorded. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. government site. Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants Irwin v. Alan Loren, M.D. Unauthorized use of these marks is strictly prohibited. Before Can Postoperative Radiographs Accurately Identify Screw Misplacements? . J Bone Joint Surg 73A:11791184, 1991. Please try after some time. Fortunately, most of the complications were minor and transient. 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. 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. 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). 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. 2018;29(4):397406. 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. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Show more. 6. 0 attorneys agreed. 2007;106(6):11081114. However, the misplacement of pedicle screws can lead to disastrous complications. 37. Please enable scripts and reload this page. Spine 17:834837, 1992. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Nottmeier EW, Seemer W, Young PM. Facebook Google Plus Youtube RSS Email. 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. Critically revising the article: all authors. I won't be at the office but I will check my voice mail. 8. Eur Spine J. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Privacy Policy. 2020;162(6):13791387. Epub 2021 Aug 28. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. 2. Intraoperative pedicle fractures requiring further points of fixation. 2014;20(6):636643. 2,24,28,36. All the incidental dural tears were repaired immediately and produced no clinical sequelae. 5 Those authors recommend that particular care should be taken in inserting the washers without cross threading and ensuring that they are locked down tightly, with an adequate length of rod protruding beyond the screw. 2014;75(6):609613. 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. 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. 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. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. 33. pedicle screw misplacement malpractice Friedlander and Bradley will pay half of the $2.25 million. 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? Accuracy of C2 pedicle screw placement using the anatomic freehand 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 Dr. Abd-El-Barr is a consultant for Spineology. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. Patient safety: disclosure of medical errors and risk mitigation. Analysis and interpretation of data: Sankey, TT Than. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. CT-navigation versus fluoroscopy-guided placement of pedicle screws at Agarwal N, Gupta R, Agarwal P, et al. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. The amount awarded was not significantly different across US regions (p = 0.9; Fig. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Br J Neurosurg. Epub 2022 Oct 29. Introduction. A rod is used to hold the vertebra together to allow fusion to occur. NCI CPTC Antibody Characterization Program. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. 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 ]. Please try again soon. were excluded from analysis. Results: Hardware problems were those related to the physical change of metal and screw position. In six patients (5.3%) with degenerative spine disease, the disc material had been removed. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). J Pediatr Orthop. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. Drafting the article: Sankey. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. 2018;83(5):9971006. Pullout strength of misplaced pedicle screws in the thoracic and lumbar
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