The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. What can spine surgeons do to improve patient care and avoid medical negligence suits? PMC Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Plaintiff-awarded cases by US region (left). Clin Orthop 203:126134, 1986. 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 Spinal Disord Tech. Review of neurosurgery medical professional liability claims in the United States. 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. 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. Forty-seven general complications were seen in 41 patients (36.5%). Svider PF, Kovalerchik O, Mauro AC, et al. However, only a few complications were related to a poor clinical outcome. Clinical Orthopaedics and Related Research411:86-94, June 2003. were excluded from analysis. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Spine 19(20 Suppl):2279S2296, 1994. Epstein NE. South Med J 62:17, 1969. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. Summary of background data: Spine 13:952953, 1988. Spine 18:11601172, 1993. Neurologic injury. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Melissa Nyquist required a lumbar back fusion for a herniated disc at the L4-5 level. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. In White AH, Rothman RH, Ray CD (eds). 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). Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Spine 16:576579, 1991. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Both of these patients complained of thigh pain but refused any additional 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. Waddell G, Kummell EG, Lotto WN, et al: Failed lumbar disc surgery and repeat surgery following industrial injuries. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. Orthop Trans 11:99, 1987. An official website of the United States government. Methods. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Agarwal N, Gupta R, Agarwal P, et al. Insuring spinal neurosurgery. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. 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. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. 18. 8600 Rockville Pike Spine 13:696706, 1988. 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. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. HHS Vulnerability Disclosure, Help Pedicle screw insertion in the thoracolumbar spine. Eur Spine J. Svider PF, Husain Q, Kovalerchik O, et al. I won't be at the office but I will check my voice mail. official website and that any information you provide is encrypted Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Show more. Rovit RL, Simon AS, Drew J, et al. Careers. None of these complications resulted in additional surgery or in a significant increase of morbidity. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. All case demographics are summarized in Table 1. 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). J Bone Joint Surg 62A:13021307, 1980. 2 One of the first obstacles regarding . Nahed BV, Babu MA, Smith TR, Heary RF. Thu, May 27th, 2021. The accuracy of pedicle screw placement using intraoperative image guidance systems. 14. 2017;42(3):177185. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. The instrumentation and bone graft were left in place in these patients (total infection rate, 2.7%). In this example, the surgeon replaced the misplaced screw prior to leaving the operating room, which arguably played a significant role in the jury ruling in favor of the defendant (surgeon). 5. J Bone Joint Surg 73A:11791184, 1991. government site. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. Quraishi NA, Hammett TC, Todd DB, et al. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Epstein NE. Ann R Coll Surg Engl. 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. Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. 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. States were then grouped by US region and case year by 5-year intervals. Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. However, the highest offer had been a combined $300,000 from the two defendants. 2. 2009;10(1):3339. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. Spine (Phila Pa 1976). Clin Orthop 203:717, 1986. Arthrodesis was questionable in eight asymptomatic patients (7.1%). Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. J Bone Joint Surg 61A:201207, 1979. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. 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. The amount awarded was not significantly different across US regions (p = 0.9; Fig. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiff's spine. * The medicolegal landscape of spine surgery: how do surgeons fare? Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Lorenz M, Zindrick M, Schwaegler P, et al: A comparison of single level fusion with and without hardware. The screws were needed to stabilize the spine and fix the fused vertebrae in place. The medicolegal landscape of spine surgery: how do surgeons fare? You are talking one of the most complicated area of the law. Pedicle screws have been used to treat spinal disorders, including those caused by spinal cancer, congenital anomalies, trauma, and chronic pain syndromes. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. 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. The https:// ensures that you are connecting to the Linking and Reprinting Policy. 33. Rynecki ND, Coban D, Gantz O, et al. Except for two patients with spinal metastatic disease, all other patients received an iliac crest autologous bone grafts. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. A.J. National Library of Medicine 2014;21(3):320328. Per-patient analysis showed 23 (18.11%) of patients had all screws AP. Methods: Two patients had early postoperative postural headache that disappeared after removal of the misplaced screw. 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. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. At the trials close, the plaintiffs attorney had asked the jury to return a $5.3 million verdict and had made a prior demand to settle the medical malpractice lawsuit for $1 million. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. Taylor CL. 2. Study design: However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. 3. Seven hundred sixty-three screws were inserted in 138 patients. The most frequent primary injury listed for a lawsuit was nerve root injury, present in 81.0% (n = 17) and 74.5% (n = 35) of plaintiff- and defendant-awarded cases, respectively (p = 0.7). Reviewed submitted version of manuscript: all authors. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. 8. The suit claimed Dr. Friedlander failed to diagnose and treat the mispositioned screw in a timely manner, leading the plaintiff to develop pain in his right leg, numbness in his right calf and weakness in his right toes. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. Laryngoscope. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Pitfall: Unstable injuries. Characteristics of medicolegal cases related to misplaced screws in spine surgery. Spine 17:349355, 1992. A total of 69 patients (mean age, 67.416 . 3. Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 37. 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. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults, Spinal fusion in the United States: analysis of trends from 1998 to 2008, Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws, The accuracy of pedicle screw placement using intraoperative image guidance systems, 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, Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial, Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients, Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO, Accuracy of pedicle screw placement and clinical outcomes of robot-assisted technique versus conventional freehand technique in spine surgery from nine randomized controlled trials: a meta-analysis, Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison, Verdict/Settlement Search and Inclusion/Exclusion Criteria, Plaintiff Claim and Index Surgery Information, Impact of Medical Malpractice on Neurosurgeon and Orthopedic Surgeon Careers, Financial Burden of Medical Malpractice Claims Related to Misplaced Pedicle and/or Lateral Mass Screws, Frequency of Misplaced Pedicle and Lateral Mass Screws in Spine Surgery, Strategies to Improve the Accuracy of Screw Placement in Spine Surgery, Top 25 Cited Gamma Knife Surgery Articles - Trigeminal Neuralgia, Top 25 Cited Gamma Knife Surgery Articles - Volume 111, https://doi.org/10.3171/2020.8.FOCUS20600, https://www.bls.gov/data/inflation_calculator.htm, Volume 49 (2020): Issue 5 (Nov 2020): Medicolegal issues in neurosurgery, Single vs multiple misplaced screw(s), no. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. The .gov means its official. doi: 10.1097/BPO.0000000000001828. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Neurosurgeons and orthopedic surgeons were named as the defendant in an equal number of cases, and the decision for the plaintiff versus the defendant was also similar between specialties.