All Rights Reserved. J Bone Joint Surg 62A:13021307, 1980. 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. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. Malpractice litigation following spine surgery. Instrumentation removal is an option for patients with successful arthrodesis, but remains controversial. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. Hardware problems were those related to the physical change of metal and screw position. What can spine surgeons do to improve patient care and avoid medical negligence suits? The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. 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. All of these patients were asymptomatic and had satisfactory final clinical outcomes (Fig 2). Results: J Neurosurg Spine. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Many technological advances have been made over the past several decades in an effort to improve the accuracy of screw placement in spine surgery.3436 For example, 3D fluoroscopybased image guidance has been shown to decrease the pedicle breach rate in several studies compared to the rate with 2D fluoroscopic guidance or the freehand technique, particularly in deformity and revision surgeries.21,34,36,37 CT guidance or intraoperative confirmation has also been shown to further improve the accuracy of pedicle screw placement,3638 with reported accuracy rates of 89%100% reported in the literature, depending on the authors breach criteria.35 However, it is important to note that the use of this technology is often accompanied by a lower threshold for intraoperative screw revision, sometimes leading to higher rates of replaced screws.33 Arguably, these improved trajectories may avoid iatrogenic neurological deficits due to prolonged nerve root compression or even improve the stability of the construct;34,37 however, prospective studies of long-term outcomes and rates of revision surgery remain sparse in the literature. Pedicle screw insertion techniques: an update and review of the 21. 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%). 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. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. Dr. Abd-El-Barr is a consultant for Spineology. 3. Spine 16(8 Suppl):S422427, 1991. 2019;19(7):12211231. Pullout strength of misplaced pedicle screws in the thoracic and lumbar There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). A total of 2396 screws were placed accurately (87.96%). Spinal fusion procedures are increasingly performed each year, with Deyo et al. 2018;27(9):23392347. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Malpositioned pedicle screw resulting | Legal Advice - LawGuru In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass 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. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Rather, the defense demonstrated that although the misplaced screw had in fact irritated the L4 nerve root for the six days before it was removed, the related symptoms resolved with the screws removal. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Epstein NE. 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. 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. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 2. 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. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. (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. Din RS, Yan SC, Cote DJ, et al. Summary of background data: I won't be at the office but I will check my voice mail. Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Unauthorized use of these marks is strictly prohibited. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws. Spine 19:25842589, 1994. 2013;32(1):111119. 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. 26. J Neurosurg Spine. 10. Spine 19(20 Suppl):2279S2296, 1994. Spine 18:11601172, 1993. 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. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. ABSTRACT: Pedicle screw loosening has been implicated in recurrent back pain after lumbar spinal fusion, but the degree of loosening has not been systematically quantied in patients. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 14. 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. Wolters Kluwer Health Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 2017;31(3):287288. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. Analysis and interpretation of data: Sankey, TT Than. Pedicle screw insertion - AO Foundation 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. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 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. The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. Review of neurosurgery medical professional liability claims in the United States. . Pitfall: Unstable injuries. 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). 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 2021 Jul 1;41(Suppl 1):S80-S86. 2018;83(5):9971006. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. 2014;20(6):636643. 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). 1. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Drafting the article: Sankey. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Statistical analysis: Sankey. Cerebrospinal fluid fistulas. 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. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. 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. FOIA 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. Pedicle screw replacement in spinal surgery - The MDU 2005;293(21):26092617. Surg Neurol Int. Spine fixation included one segment in 27 patients, two segments in 38 patients, three segments in 42 patients, and more than three segments in five patients. 2022 Sep 15;14(9):6323-6331. eCollection 2022. NCI CPTC Antibody Characterization Program. 2009;10(1):3339. 2018;29(4):397406. 38. Each side was judged separately. 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%). In the other patient, L4L5 float arthrodesis was done. Re: malpositioned pedicle screw resulting in additional surgery and disability. Spine 17:834837, 1992. However, the misplacement of pedicle screws can lead to disastrous complications. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. Defensive medicine: a culprit in spiking healthcare costs. 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. Bookshelf Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Smith TR, Hulou MM, Yan SC, et al. The contact form sends information by non-encrypted email, which is not secure. The average age of the patients was 47 years and the average followup was 35 months. Results: A total of 2724 screws were placed in 127 patients. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Laryngoscope. 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. 13. Ann Thorac Surg. To investigate intraoperative reinsertion of percutaneous pedicle screw (PPS) with intraoperative CT-based navigation and to evaluate the rate of deviation of PPS at postoperative radiographic examination. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. 18. 15. 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. 7. 29. Patient Suffers Permanent Nerve Damage From Spinal Surgery

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