Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. 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). Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. 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. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Balch CM, Oreskovich MR, Dyrbye LN, et al. Neurosurgery. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. I won't be at the office but I will check my voice mail. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 21. J Bone Joint Surg 62A:13021307, 1980. Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. Am J Transl Res. Defendant-awarded cases by US region (right). 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. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Fager CA. 2019;19(7):12211231. Deyo RA, Mirza SK, Martin BI. 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. 34. Clin Orthop 203:126134, 1986. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). 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. Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. An official website of the United States government. J Bone Joint Surg 45A:11591170, 1963. 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. 2020;45(2):E111E119. Orthopedics. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. 3. 2013;123(9):20992103. Spine 6:615619, 1981. 4. 2012;41(2):6973. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. 2013;32(1):111119. Disclaimer. The rate of reoperation for screw misplacement per screw was 0.17%. However, the highest offer had been a combined $300,000 from the two defendants. 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. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. 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Studdert DM, Mello MM, Sage WM, et al. Orthop Trans 11:99, 1987. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. J Neurosurg. Spine 13:696706, 1988. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. 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. Methods. 2014;20(2):196203. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. National Library of Medicine All case demographics are summarized in Table 1. Please enable scripts and reload this page. Rajasekaran S, Bhushan M, Aiyer S, et al. 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. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Level of evidence: The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Neurosurgery. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Conception and design: Sankey, KD Than. J Neurosurg Spine. George Sapkas, MD, DSc; and Panayiotis J. Papagelopoulis, MD, DScGuest Editors. 2014;20(6):636643. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). FOIA 2014;174(11):18671868. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Would you like email updates of new search results? Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 2022 Sep 15;14(9):6323-6331. eCollection 2022. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Spine 19(20 Suppl):2279S2296, 1994. Unable to load your collection due to an error, Unable to load your delegates due to an error. All the operations were done by one surgeon (PK). Several limitations should be carefully considered when interpreting our results. South Med J 62:17, 1969. Cerebrospinal fluid fistulas. J Spinal Disord Tech. J Neurosurg Spine. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Epstein NE. 23. This occurred on only one side and the correction achieved by the instrumentation was maintained. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. Spinal fusion in the United States: analysis of trends from 1998 to 2008. 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. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. 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. Before Din RS, Yan SC, Cote DJ, et al. Stauffer RN, Coventry MB: Posterolateral lumbar-spine fusion: Analysis of the Mayo clinic series. None of these complications resulted in additional surgery or in a significant increase of morbidity. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. 33. Hecht N, Kamphuis M, Czabanka M, et al. Objective: Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. J Neurosurg Spine. Facebook Google Plus Youtube RSS Email. 3. However, the misplacement of pedicle screws can lead to disastrous complications. Results: Rynecki ND, Coban D, Gantz O, et al. 2012;7(6):e39237. 2. 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. 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. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. 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. Surg Neurol Int. 19. Problems at the junctions of the instrumented spine were seen in five patients (4.5%). Spine 17:834837, 1992. PMC Problems of balance were coronal (scoliosis greater than 5 or trunk shift greater than 5 mm) as seen on the AP radiograph taken with the patient standing or sagittal (failure to obtain or maintain lumbar lordosis). Epub 2014 Jun 13. We serve the following localities: Cook County including Arlington Heights, Barrington, Berwyn Township, Chicago, Des Plaines, Glenview, Orland Park, Palos Park, Schaumburg, and Tinley Park; DuPage County including Downers Grove, Naperville, and Bolingbrook; Kane County including Aurora, Elgin and Geneva; Lake County including Waukegan; and Will County including Joliet. Results. 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. and 17.1% of the patients included had at least one screw misplaced. J Neurosurg. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Epub 2021 Aug 28. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. 2 One of the first obstacles regarding . 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. Under the high-low agreement, Drs. Ann R Coll Surg Engl. A total of 2724 screws were placed in 127 patients. 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. Spine 6:263267, 1981. Dr. Shaffrey has received grants from the NIH and Department of Defense. 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. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. 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. Spine (Phila Pa 1976). The link was not copied. Federal government websites often end in .gov or .mil. Friedlander and Bradley will pay half of the $2.25 million. The contact form sends information by non-encrypted email, which is not secure. The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). Guillain A, Moncany AH, Hamel O, et al. Eur Spine J. 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. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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. Plaintiff-awarded cases by US region (left). 31. L3S1 spine arthrodesis was done in the first patient but the correction of scoliosis was not sufficient and coronal imbalance persisted after surgery, which accelerated the degeneration of the level just above the arthrodesis. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Roy-Camille R, Roy-Camille M, Demeulenaere C: Osteosynthese du rachis dorsal, lombaire et lombo-sacre par plaque metalliques vissees dans les pedicules vertebraux et es apophyses articularies. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). The amount awarded was not significantly different across US regions (p = 0.9; Fig. Nahed BV, Babu MA, Smith TR, Heary RF. The medicolegal landscape of spine surgery: how do surgeons fare? Can Postoperative Radiographs Accurately Identify Screw Misplacements? 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. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. 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. Spine 8:970981, 1996. Re: malpositioned pedicle screw resulting in additional surgery and disability. Lehmann TR, LaRocca HS: Repeat lumbar surgery: A review of patients with failure from previous lumbar surgery treated with spinal canal exploration and lumbar spine fusion. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. A retrospective review of charts, XRs and low-dose CT scans of 127 patients who underwent spinal fusion with pedicle screws for spinal deformity was performed. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. 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. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. doi: 10.1097/BPO.0000000000001828. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. Your current browser may not support copying via this button. 32. Dr. Abd-El-Barr is a consultant for Spineology. Methods: The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. A p < 0.05 was considered statistically significant. Cookie Policy. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. 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. 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. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Malpractice issues in neurological surgery. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Epub 2014 Apr 4. 2018;83(5):9971006. shooting in valdosta leaves one dead 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. Per-patient analysis reveals more concerning numbers toward screw misplacement. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. 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. 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. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . may email you for journal alerts and information, but is committed 27. However, the misplacement of pedicle screws can lead to disastrous complications. Nayar G, Blizzard DJ, Wang TY, et al. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. 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. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. Ahmadi SA, Sadat H, Scheufler KM, et al. 28. 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. 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. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Br J Neurosurg. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. In their meta-analysis of nine randomized controlled trials, Li et al. 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. laterally placed screws and the azygous vein on the right (T5-T11). Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. Spine (Phila Pa 1976). 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. 2012;89(10):7071. 2022 Dec;31(12):3544-3550. doi: 10.1007/s00586-022-07427-0. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. JAMA. Arthrodesis was questionable in eight asymptomatic patients (7.1%).

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