Spine (Phila Pa 1976). Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. Spine J. Study design: 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. Epstein NE. Spine 18:23252326, 1993. Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Drafting the article: Sankey. 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. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. J Neurosurg Spine. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. The rate of medical complications was 8%. Dr. Abd-El-Barr is a consultant for Spineology. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. NCI CPTC Antibody Characterization Program. 2014;21(3):320328. The average age of the patients was 47 years and the average followup was 35 months. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. 10. 1. Screw misplacement. Linking and Reprinting Policy. Jena AB, Seabury S, Lakdawalla D, Chandra A. 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. 16. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . HHS Vulnerability Disclosure, Help Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. 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. 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. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem. Spine 6:615619, 1981. The plaintiff underwent revision surgery in May 2013. Of note, the award amount for one settlement case was undisclosed. Although the rate of the reported complications was high, the final outcome of the patients was not affected significantly. 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. St Louis, CV Mosby 322327, 1987. 2022 Sep 15;14(9):6323-6331. eCollection 2022. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Neurosurgery. Each side was judged separately. Don't jump in get legal help. 21. It argued that the foot drop was unavoidable and due to the surgeons need to manipulate the right L5 nerve root in order to remove Nyquists herniated disc during the spinal fusion surgery. 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. concluded that the robot-assisted technique was significantly more accurate than the traditional freehand technique.39 Despite the learning curve and initial cost of obtaining technologies such as 3D fluoroscopic devices, intraoperative CT, or robotic navigational systems, the routine use of these technologies for intraoperative imaging confirmation and potential revision of misplaced screws may help spine surgeons avoid inadvertent iatrogenic morbidity for their patients and potential litigation. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. The initial search using the terms above returned 3654 cases. Agarwal N, Gupta R, Agarwal P, et al. $ = US$. 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. Results: A total of 2724 screws were placed in 127 patients. Federal government websites often end in .gov or .mil. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. A large number of studies have reported that in conventional thoracolumbar surgery, compared with traditional freehand screw placement, the accuracy of intraoperative pedicle screw placement has been improved with O-arm intraoperative navigation technology. Clin Orthop 115:130139, 1976. 29. The third patient, who had central spinal stenosis, was treated by decompression alone. Ann Thorac Surg. Spine 19(20 Suppl):2279S2296, 1994. National Library of Medicine Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. MeSH 35. JAMA. 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. 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. Bethesda, MD 20894, Web Policies This device was used with an early version of the Cotrel-Dubousset instrumentation to provide sacral fixation and it is rarely used since the more widespread use of newer spine fixation systems. States were then grouped by US region and case year by 5-year intervals. 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. 8. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 5. Although the rationale for using pedicle screw fixation is fairly clear, controversy continues regarding the application of pedicle instrumentation for spine arthrodesis, especially on the degenerative lumbar spine. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 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). Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Objective: * Spine 6:263267, 1981. What can spine surgeons do to improve patient care and avoid medical negligence suits? Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 2012 Feb 1;37(3):E188-94. The patient had to undergo a subsequent surgery to remove the pedicles. Mean amounts awarded SD to plaintiffs by jury trial (n = 13) versus settlement/arbitration (n = 7), adjusted for inflation as of April 2020. Insuring spinal neurosurgery. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Would you like email updates of new search results? Seabury SA, Chandra A, Lakdawalla DN, Jena AB. Spine 16:576579, 1991. The https:// ensures that you are connecting to the Fager CA. Clin Orthop 227:1023, 1988. Scarone P, Vincenzo G, Distefano D, et al. J Bone Joint Surg 73A:11791184, 1991. One hundred four of the 112 patients had a posterior procedure. 2018;83(5):9971006. The radiology results showed that the surgical screw placed at the right L4-5 area had breached the medial wall and was actually extending into the spinal canal. Rajasekaran S, Bhushan M, Aiyer S, et al. 2020;45(2):E111E119. Friedlander and Bradley will pay half of the $2.25 million. The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. 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). With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. 2012;89(10):7071. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). . 36. The average followup was 35 months (range, 1851 months). It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Routine CT scans were taken in all patients. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. Spine (Phila Pa 1976). JAMA Intern Med. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). PLoS One. Importantly, these advanced technologies are not always readily available or the standard of care and cannot supplant a thorough understanding of operative anatomy, a high-quality surgical technique, and general complication-avoidance measures. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. However, the highest offer had been a combined $300,000 from the two defendants. Orthop Trans 11:99, 1987. Presse Med 78:14471448, 1970. 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. Rovit RL, Simon AS, Drew J, et al. 2 One of the first obstacles regarding . 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. Instead, the defense offered up an alternative explanation for Nyquists foot drop. FOIA Malpractice liability and defensive medicine: a national survey of neurosurgeons. Administrative/technical/material support: Mehta, Wang, KD Than. Potential complications may include increased pain, infection, or mechanical . Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 9. 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.

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