Results. 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. 2. 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. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Cookie Policy. None of these complications resulted in additional surgery or in a significant increase of morbidity. 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. Disclaimer. The intent is to provide relief from pain and nerve damage. 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. 2012;37(1):6776. Pedicle screw placement: Robotic assistance for greater precision Some error has occurred while processing your request. NCI CPTC Antibody Characterization Program. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement 7. J Bone Joint Surg 61A:201207, 1979. This site needs JavaScript to work properly. Epub 2021 Aug 28. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. 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. Statistical analysis: Sankey. (%), Pseudarthrosis requiring revision surgery. Orthopedics. Pedicle screw insertion techniques: an update and review of the 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). Each case was then carefully screened for relevance and sufficient data. 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). Scarone P, Vincenzo G, Distefano D, et al. Neurosurgery. 1. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. Please try again soon. J Neurosurg Spine. 39. 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. 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. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. shooting in valdosta leaves one dead Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. HHS Vulnerability Disclosure, Help 2. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 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. Summary of background data: 17. 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. 4. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Of note, the award amount for one settlement case was undisclosed. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. single homes for sale in lehigh valley, pa pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 8,24,25,32. 19. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. 4. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. 15. Each side was judged separately. Drafting the article: Sankey. Ann Thorac Surg. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction PMC Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 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. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. 36. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. 2013;123(9):20992103. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. An official website of the United States government. Neurological outcome and management of pedicle screws - PubMed There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). 2021 Jul 1;41(Suppl 1):S80-S86. 2018;27(9):23392347. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. However, the misplacement of pedicle screws can lead to disastrous complications. Facebook Google Plus Youtube RSS Email. South Med J 62:17, 1969. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. The patient had to undergo a subsequent surgery to remove the pedicles. 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. 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. 12. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. Din RS, Yan SC, Cote DJ, et al. 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. Careers. 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. Neurosurgical practice liability: relative risk by procedure type. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. The site is secure. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Bethesda, MD 20894, Web Policies A total of 2724 screws were placed in 127 patients. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. 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. Schatlo B, Molliqaj G, Cuvinciuc V, et al. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Orthop Trans 11:99, 1987. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. government site. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. 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. Am J Otolaryngol. Introduction. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Defendant-awarded cases by US region (right). JAMA. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Call me tomorrow. 3). Routine CT scans were taken in all patients. Spine 16(8 Suppl):S422427, 1991. The .gov means its official. 2. Defensive medicine in U.S. spine neurosurgery. 2011;213(5):657667. JAMA. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. Br J Neurosurg. Sethi MK, Obremskey WT, Natividad H, et al. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. 2012 Feb 1;37(3):E188-94. PLoS One. Malpositioned pedicle screw resulting | Legal Advice - LawGuru Patient-specific 3D-printed surgical guides for pedicle screw insertion Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. 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. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 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. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan Spine (Phila Pa 1976). All Rights Reserved. 34. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. Pullout strength of misplaced pedicle screws in the thoracic and lumbar 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). 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. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. CT-navigation versus fluoroscopy-guided placement of pedicle screws at 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. Patient Suffers Permanent Nerve Damage From Spinal Surgery Thoracic pedicle screw placement: Free-hand technique - Bioline Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Surg Neurol. Show more. 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. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Robotic-assisted pedicle screw placement fails to reduce overall A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Yuan HA, Garfin SR, Dickman CA, Mardjetko SM: A historical cohort study of pedicle screw fixation in thoracic, lumbar and sacral spinal fusions. Of note, the award amount for one settlement case was undisclosed. I won't be at the office but I will check my voice mail. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). and transmitted securely. 27. 2018;43(14):984990. Would you like email updates of new search results? Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. The rate of reoperation for screw misplacement per screw was 0.17%. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. 2016;102(2):358362. 3. Neurological Outcome and Management of Pedicle Screws Misplaced Totally 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 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. 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. Hardware-related failures were observed in 12 patients (10.7%). Materials and Methods Sixty . In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. 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. 2018;83(5):9971006. Epstein NE. 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. 2017;42(3):177185. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 8600 Rockville Pike 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. 24. Spine 18:18621866, 1993. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. 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 2016;25(3):716723. The accuracy of pedicle screw placement using intraoperative image guidance systems. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Hardware problems were those related to the physical change of metal and screw position. leg pain. 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). Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 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 instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Privacy Policy. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. This patient recovered completely in 6 weeks. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Epub 2014 Apr 4. Epstein NE. 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.
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