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. Ahmadi SA, Sadat H, Scheufler KM, et al. Rynecki ND, Coban D, Gantz O, et al. Surg Neurol Int. Din RS, Yan SC, Cote DJ, et al. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Quraishi NA, Hammett TC, Todd DB, et al. Epstein NE. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 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. 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). However, the misplacement of pedicle screws can lead to disastrous complications. MeSH 2018;29(4):397406. The initial search using the terms above returned 3654 cases. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Acta Neurochir (Wien). Unauthorized use of these marks is strictly prohibited. The rate of medical complications was 8%. The plaintiff will recover $2.25 million because of a high-low agreement the lawyers entered after closing arguments, the New Jersey Law Journal reports. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. 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. Clin Orthop 203:717, 1986. Rothberg MB, Class J, Bishop TF, et al. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Luque ER: Segmental spinal instrumentation of lumbar spine. Results: Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. to maintaining your privacy and will not share your personal information without However, the misplacement of pedicle screws can lead to disastrous complications. Neurosurgery. your express consent. Except for the patient with an infected pseudarthrosis who had a flat back syndrome (sagittal imbalance) develop, coronal imbalance was observed in five patients (4.5%), and ranged from 7.5 to 12 (Fig 3). 11. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. + 48 696 042 504. 2018;41(5):e615e620. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. were excluded from analysis. 9. Results. The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. National Library of Medicine One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 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. Neurosurgical practice liability: relative risk by procedure type. Spine (Phila Pa 1976). 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. Spine 19:25842589, 1994. 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). Spinal fusion procedures are increasingly performed each year, with Deyo et al. Pedicle screws are used by spine surgeons as part of a fusion in which two adjacent bones in the spine are combined together as one. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. 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. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Before Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 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. J Spine Surg. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. Todd NV. 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). 37. Li HM, Zhang RJ, Shen CL. J Neurosurg Spine. Epub 2022 Oct 29. 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. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 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. Federal government websites often end in .gov or .mil. Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. $ = US$. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . 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. 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. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. 2013;34(6):699705. Pedicle screw placement is a common procedure. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 36. 21. Can Postoperative Radiographs Accurately Identify Screw Misplacements? J Spinal Disord Tech. Studdert DM, Mello MM, Sage WM, et al. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . Instead, the defense offered up an alternative explanation for Nyquists foot drop. 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. 2014;75(6):609613. Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. 2017;31(3):287288. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. Don't jump in get legal help. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. It has a great developing technique that is used for fixation and fusion in spine surgery. and 17.1% of the patients included had at least one screw misplaced. Routine CT scans were taken in all patients. This occurred on only one side and the correction achieved by the instrumentation was maintained. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Intraoperative pedicle fractures requiring further points of fixation. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. 8 spine surgeon insights, Lumbar spinal fusion cost in the 10 largest US cities, 2 MLB players undergo offseason spine surgeries, Salem Regional Medical Center adds spine surgeon, Here's how 6 spine surgeons prepare before a busy day, Total disc replacement cost in the 10 largest US cities, Study finds surgery more effective than conventional treatment for spinal stenosis, Dr. Rick Price completes his 50th AR spine case, Orthopedic surgeon among 2 convicted in $31M Medicare fraud scheme, SSM Health sues 2 resigning orthopedic surgeons, Surgeon leaves Rothman after 12 years to establish boutique spine practice, Jury awards $9.2M in botched spine surgery case, 'The numbers don't lie': Endoscopy to become more prominent among next generation of spine surgeons, Patient sues estate of late spine surgeon, 10 surgeons on the most controversial trends in spine, Connecticut orthopedic surgeon fined, reprimanded for operating on wrong hip, Ohio neurosurgeon facing wrongful death suit, Orthopedic surgeons at SSM Health resign, plan to start independent group, Wealthiest US orthopedic surgeon has a net worth of $1.8B, Orthopedic surgeons leaving SSM Health will partner with HOPCo for independent group, Wisconsin orthopedic surgeon sanctioned in patient's death, Healthgrades' best hospitals for spine surgery: 2023, How spine surgery competition is evolving by market: New York, Arizona, California and more, Indianapolis Colts linebacker has back surgery after consultation with Dr. Robert Watkins, Former Philadelphia Eagles player wins $43.5M verdict in knee injury case, California hospital cleared in counterfeit spine implant case, Georgia orthopedic clinic settles kickback suit, 22 hospitals ranked top 25 orthopedic hospitals 3+ years in a row, Stryker vs. Johnson & Johnson vs. Zimmer Biomet: How they compare in Q3, Neurosurgeon sentenced 5 years for accepting $3.3M in bribes, 12 surgeons who are leaving orthopedic groups for private practices, SSM Health canceling procedures as 11 orthopedic surgeons begin early departure, Aetna revises lumbar disc replacement policy, Indiana orthopedic surgeon settles Medicaid fraud allegations for $700K, 2 orthopedic hospitals facing Medicare readmission penalties, University of Toledo Medical Center suspends orthopedic chair, Here's what HOPCo's 1st Wisconsin partnership will look like, 2 Florida orthopedic providers merge to form 17-physician practice, 'This system is unsustainable': Why orthopedic surgeons do not feel fairly compensated, Orthopedic surgeon convicted for $31M staged fall scheme, Orthopedic surgeon buys $2M Chicago church, plans to convert to community hub, New Hampshire orthopedic surgeon arrested for alleged patient abuse, 8th Annual Becker's Health IT + Digital Health + RCM Annual Meeting. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). 2007;106(6):11081114. A.J. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. West III JL, Bradford DS, Ogilvie JW: Complications of the variable screw pedicle screw fixation. Orthop Trans 11:99, 1987. 1). The .gov means its official. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 2021 Jul 1;41(Suppl 1):S80-S86. 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. 25. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. J Neurosurg Spine. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. 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. Yuan et al 37 reported that the use of spinal instrumentation is associated with higher rate of infection (3%6%), neurologic injury (1%5%), instrumentation failure (6%10%), and reoperation (20%), compared with in situ arthrodeses. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. PLoS One. Spine 15:908912, 1990. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Presse Med 78:14471448, 1970. doi: 10.1097/BRS.0b013e31822a2e0a. 2016;25(3):716723. A rod is used to hold the vertebra together to allow fusion to occur. JAMA Intern Med. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Bethesda, MD 20894, Web Policies Spine 14:472476, 1989. 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 ]. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. Defensive medicine in U.S. spine neurosurgery. and transmitted securely. Dr. Abd-El-Barr is a consultant for Spineology. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. However, only a few complications were related to a poor clinical outcome. Materials and Methods Sixty . In White AH, Rothman RH, Ray CD (eds). 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. 2016;102(2):358362. The patient suffered permanent nerve damage as a result of the puncture. Epub 2014 Apr 4. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 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. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. 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? 27,30 Infected pseudarthrosis developed in one patient (0.9%) with an L4S1 arthrodesis, and the instrumentation was removed 18 months later resulting in a flat back syndrome. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. 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. Schatlo B, Molliqaj G, Cuvinciuc V, et al. Methods. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Spine Deform. leg pain. Statistical analysis: Sankey. A total of 2396 screws were placed accurately (87.96%). Disclaimer. 16. 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. Makhni MC, Park PJ, Jimenez J, et al. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). 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. Facebook Google Plus Youtube RSS Email. 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 cost of defensive medicine on 3 hospital medicine services. A total of 69 patients (mean age, 67.416 . 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. Conversely, Nyquists foot drop did not resolve after the screw was removed, which begged the question of whether the foot drop was in fact caused by the misplaced screw. Conception and design: Sankey, KD Than. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. 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). One hundred four of the 112 patients had a posterior procedure. Your message has been successfully sent to your colleague. Pedicle screw insertion in the thoracolumbar spine. single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa Mason A, Paulsen R, Babuska JM, et al. Deyo RA, Mirza SK, Martin BI. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. 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. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. PMC 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. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. All Rights Reserved. Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. The intent is to provide relief from pain and nerve damage. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. Legal liability in iatrogenic orbital injury. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). The rate of reoperation for screw misplacement per screw was 0.17%. Spine J. Privacy Policy. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. This site needs JavaScript to work properly. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Despite this problem, the clinical result was excellent. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Two patients with associated injuries in the lower limbs had deep venous thrombosis develop, three patients had pneumonia develop, and four patients with neurologic impairment had urinary tract infections develop. 6.