pedicle screw misplacement malpractice

The medicolegal landscape of spine surgery: how do surgeons fare? The pedicle screws judged as misplacement. a Medial minor perforation 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. JAMA. Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. Spine 13:952953, 1988. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. . 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). In White AH, Rothman RH, Ray CD (eds). Whitecloud et al 35 reported an overall 45% rate of minor and major complications, with the rate of complications increasing to 63% in patients who had previous lumbar surgery. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Patient Suffers Permanent Nerve Damage From Spinal Surgery Eur Spine J. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. 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. Spine 24:23522357, 1999. Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? Rovit RL, Simon AS, Drew J, et al. Guillain A, Moncany AH, Hamel O, et al. Clin Orthop 115:130139, 1976. 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. 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. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Rajasekaran S, Bhushan M, Aiyer S, et al. There were two complete degenerations of the upper disc, one central canal stenosis, and two asymptomatic disc space narrowings and retrolistheses. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. FOIA PDF Intraoperative biomechanics of lumbar pedicle screw loosening following All the operations were done by one surgeon (PK). In the current study, the arthrodesis rate of 89.4% compares favorably with other previously reported series in the spinal literature, most of which use radiographic means to access the status of the spinal arthrodesis. Privacy Policy. 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. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. may email you for journal alerts and information, but is committed After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. 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). 8. [] The accuracy for free-hand screw placement technique varies from 69% to 94%. Malpractice claims in spine surgery in Germany: a 5-year analysis. Am J Orthop. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. Sethi MK, Obremskey WT, Natividad H, et al. Jena AB, Seabury S, Lakdawalla D, Chandra A. Using chi square analysis, statistically significant correlation was seen between disc space narrowing and loss of postoperative correction (p < 0.01). Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. A total of 2724 screws were placed in 127 patients. 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 . Neurosurgery. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. 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). 29. ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Cookie Policy. The screws were needed to stabilize the spine and fix the fused vertebrae in place. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. Median screw misplacement rate was 10% in group A and 13% in group B. Summary of background data: 20. Spine 17:834837, 1992. 38. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. 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. Balch CM, Oreskovich MR, Dyrbye LN, et al. 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). Spine 6:263267, 1981. Introduction. 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). Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Your message has been successfully sent to your colleague. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. 2011;24(1):1519. Spine 18:983991, 1993. 2014;20(6):636643. These numbers are in line with the current literature. 2021 Nov;9(6):1541-1548. doi: 10.1007/s43390-021-00377-5. Would you like email updates of new search results? Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. 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%). 30. 2020;162(6):13791387. Defensive medicine in U.S. spine neurosurgery. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 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. Can Postoperative Radiographs Accurately Identify Screw Misplacements? 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. Fager CA. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Spine 13:10121018, 1988. Both of these patients complained of thigh pain but refused any additional surgery. MeSH 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. The intent is to provide relief from pain and nerve damage. Data is temporarily unavailable. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. 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. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Patient safety: disclosure of medical errors and risk mitigation. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 2012;89(10):7071. The plaintiff underwent revision surgery in May 2013. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. 2011;365(7):629636. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. 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 J Bone Joint Surg 73A:11791184, 1991. 2012 Feb 1;37(3):E188-94. JAMA. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. This site needs JavaScript to work properly. 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. South Med J 62:17, 1969. 1. Neurosurgery. True accuracy of percutaneous pedicle screw placement in thoracic and Copyright 2023 Becker's Healthcare. Spine 19:25842589, 1994. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Neurological Outcome and Management of Pedicle Screws Misplaced Totally On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Spine (Phila Pa 1976). 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. All Rights Reserved. Pedicle screw placement: Robotic assistance for greater precision In the other patient, L4L5 float arthrodesis was done. Eur Spine J. 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. leg pain. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. The rate of medical complications was 8%. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Pullout performance comparison of pedicle screws based on cement Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. Critically revising the article: all authors. 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. 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. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. J Spine Surg. Wolters Kluwer Health Study design: Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Pedicle instrumentation in the thoracolumbar and lumbar spine is a technically challenging procedure. This patient recovered completely in 6 weeks. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Seven hundred sixty-three screws were inserted in 138 patients. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Methods: 26. 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. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. 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. 35. Level of evidence: 2013;34(6):699705. Spine 16(8 Suppl):S422427, 1991. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. J Pediatr Orthop. Spine 13:696706, 1988. National Library of Medicine 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. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. Spine 15:1114, 1990. Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. 11. Delayed open treatment of aortic penetration by a thoracic pedicle Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. Spine 18:18621866, 1993. Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. $ = US$. 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. However, despite the apparent widespread use of pedicle system fixation, few studies of problems and particularly complications have been published. To prevent the development of pseudarthrosis, we think it is important for surgeons to apply the following five technical principles: the proper-sized pedicle screw has to be inserted on the first attempt; repeated manipulation in setting instruments must be avoided; anterior penetration of the screw into the sacrum and insertion of two screws in each side are advocated for fixing the lumbosacral junction; industrious and detailed decortication of the posterior elements must be developed fully; and the use of autologous bone graft is recommended. 15. Forty-seven general complications were seen in 41 patients (36.5%). Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Am J Otolaryngol. single homes for sale in lehigh valley, pa 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. Insuring spinal neurosurgery. 2020;45(2):E111E119. 2019;19(7):12211231. Epub 2014 Jun 13. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect 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. The patient suffered permanent nerve damage as a result of the puncture. What can spine surgeons do to improve patient care and avoid medical negligence suits? 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. 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. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). Bydon M, Xu R, Amin AG, et al. The medicolegal landscape of spine surgery: how do surgeons fare? The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. 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.