Copyright © 2023 Becker's Healthcare. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Am J Otolaryngol. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. These numbers are in line with the current literature. 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%). 3. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Methods: 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). 34. 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. Harrington and Tullos 11 first reported the technique of transpedicle screw fixation, and Roy-Camille et al 23 popularized the first practical method of pedicle screw fixation. Nahed BV, Babu MA, Smith TR, Heary RF. The medicolegal landscape of spine surgery: how do surgeons fare? 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. Studdert DM, Mello MM, Sage WM, et al. Bethesda, MD 20894, Web Policies Clin Orthop 284:8090, 1992. 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. JAMA. 4. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. J Neurosurg Spine. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. NCI CPTC Antibody Characterization Program. 0 attorneys agreed. 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. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Spine (Phila Pa 1976). Intraoperative pedicle fractures requiring further points of fixation. 2012;89(10):7071. The screws were needed to stabilize the spine and fix the fused vertebrae in place. 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. 144 Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Privacy Policy. All the incidental dural tears were repaired immediately and produced no clinical sequelae. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. 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. Surg Neurol. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Insuring spinal neurosurgery. 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. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. 19. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. J Pediatr Orthop. Spine 18:18621866, 1993. The initial search using the terms above returned 3654 cases. 4). Under the high-low agreement, Drs. Balch CM, Oreskovich MR, Dyrbye LN, et al. The contact form sends information by non-encrypted email, which is not secure. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Some error has occurred while processing your request. In the remaining patients, the standard construct was three-segment fixation spanning four vertebrae and three discs, two above and one below the fractured vertebra, using six screws. 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. Spine 13:696706, 1988. 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. Clin Orthop 227:1023, 1988. Call me tomorrow. 2017;31(3):287288. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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. 2011;24(1):1519. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. Screw misplacement. The screws were needed to stabilize the spine and fix the fused vertebrae in place. Instead, the defense offered up an alternative explanation for Nyquists foot drop. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. 38. Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation Nickl v. Barry S. Rosen, M.D. All Rights Reserved. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 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. 37. Facebook Google Plus Youtube RSS Email. Please try after some time. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Orthopedics. 2021 Jul 1;41(Suppl 1):S80-S86. Ahmadi SA, Sadat H, Scheufler KM, et al. They both had motor deficits from which 1 patient recovered completely. 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). J Neurosurg Spine. 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. The cost of defensive medicine on 3 hospital medicine services. Spine J. Statistical analysis: Sankey. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Federal government websites often end in .gov or .mil. doi: 10.1097/BRS.0b013e31822a2e0a. J Spine Surg. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 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). Epstein NE. Malpractice claims in spine surgery in Germany: a 5-year analysis. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. Malpractice issues in neurological surgery. 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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. 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. 2 One of the first obstacles regarding . 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. Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. Elizabeth Hofheinz, M.P.H., M.Ed. Methods. The average followup was 35 months (range, 1851 months). However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. 2016;25(3):716723. The patient suffered permanent nerve damage as a result of the puncture. JAMA. Spine Deform. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. Fager CA. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. Br J Neurosurg. To reinforce spinal fixation, we have proposed a construct with segmental pedicle fixation two levels above and one level below the injured level and insertion of a screw deep into the pedicle, providing more contact area between screw head and bone and reducing the moment arm of the bending stress. Spine 14:472476, 1989. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. 2017;42(3):177185. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. 2013;32(1):111119. 6 In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Hecht N, Kamphuis M, Czabanka M, et al. All the operations were done by one surgeon (PK). 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. Makhni MC, Park PJ, Jimenez J, et al. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. This patient recovered completely in 6 weeks. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Pullout performance comparison of pedicle screws based on cement application and design parameters Tolga Tolunay, Cemile Bagl, Teyfik Demir, Mesut E Yaman, and Arslan K Arslan Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 2015 229: 11 , 786-793 Download Citation Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. 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. Hardware problems were those related to the physical change of metal and screw position. 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. Jena AB, Seabury S, Lakdawalla D, Chandra A. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Better strategies need to be devised for evaluation of screw placement, including establishment of a national database of deformity surgery, use of intra-operative image guidance, and reevaluation of postoperative low-dose CT imaging. J Neurosurg Spine. Summary of background data: Show more. 2. Epub 2014 Apr 4. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. J Neurosurg Spine. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. Agarwal N, Gupta R, Agarwal P, et al. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Am J Orthop. Quraishi NA, Hammett TC, Todd DB, et al. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Over 40% of patients had screws with either some/major concern. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Epub 2022 Oct 29. In addition, seven (6.3%) dural tears occurred during the decompression and none occurred during instrumentation. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. Author links open overlay panel Mohamad Bydon a b 1, Dimitrios Mathios a b 1, Mohamed Macki a b, Rafael De la Garza-Ramos a b, Nafi Aygun c, Daniel M. Sciubba a, Timothy F. Witham a, Ziya L. Gokaslan a b, Ali Bydon a b, Jean-Paul Wolinksy a. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. Bookshelf All case demographics are summarized in Table 1. 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. Please enable scripts and reload this page. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Clin Orthop 203:717, 1986. 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. 35. 26. Start; O firmie; Usugi; Serwis; Realizacje i porady; Kontakt Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 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. It has a great developing technique that is used for fixation and fusion in spine surgery. 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. 2014;96(4):266270. 1. Svider PF, Husain Q, Kovalerchik O, et al. 2011;365(7):629636. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). your express consent. Please enable it to take advantage of the complete set of features! The third patient, who had central spinal stenosis, was treated by decompression alone. Eur Spine J. Results. 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). 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 23. 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. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). pedicle screw misplacement malpractice. 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. The pedicle screw system is widely used in spine surgery, and it provides rigid fixation and leads to successful subsequent deformity correction and bony fusion. Bydon M, Xu R, Amin AG, et al. 29. Materials and Methods Sixty . Please try again soon. Introduction. While the majority of verdicts are found in favor of the defendant (surgeon), over 30% of cases in this study were found in favor of the plaintiff (patient), resulting in average inflation-adjusted payouts of over $1.2 million per claim over the past 25 years. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. 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. Nottmeier EW, Seemer W, Young PM. The https:// ensures that you are connecting to the Problems at the junctions of the instrumented spine were seen in five patients (4.5%). Taylor CL. Defensive medicine in neurosurgery: the Canadian experience. Legal liability in iatrogenic orbital injury. Clinical Orthopaedics and Related Research411:86-94, June 2003. 8. 12. 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. Pedicle screw placement is a common procedure. 20. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. may email you for journal alerts and information, but is committed We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment.