Spinal fusion in the United States: analysis of trends from 1998 to 2008. Under the high-low agreement, Drs. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. In unstable injuries, the segments above and below the level of injury may have a different orientation of the pedicle trajectory due to . The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. The standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 16. Spine 13:696706, 1988. Both of these patients complained of thigh pain but refused any additional surgery. Spine Deform. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. Segal J. 4). 29. 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. Koktekir E, Ceylan D, Tatarli N, Karabagli H, Recber F, Akdemir G. Spine J. J Neurosurg Spine. Elizabeth Hofheinz, M.P.H., M.Ed. sharing sensitive information, make sure youre on a federal The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. The initial search using the terms above returned 3654 cases. 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. National Library of Medicine Krag MH, Beynnon BD, Pope MH, et al: An internal fixator for posterior application to short segment of the thoracic, lumbar, or lumbosacral spine. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. The pedicle screws judged as misplacement. a Medial minor perforation Hecht N, Kamphuis M, Czabanka M, et al. Dr. Shaffrey has received grants from the NIH and Department of Defense. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. Pedicle screw placement accuracy impact and comparison between grading These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. 34. Spine 18:11601172, 1993. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Therefore, when instrumentation is to be used, the benefits must outweigh the risks. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Pedicle screw insertion - AO Foundation Spine (Phila Pa 1976). Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. 70% of Pedicle Screws are misplaced - orthostreams.com Personal consequences of malpractice lawsuits on American surgeons. pedicle screw misplacement malpractice Malpractice issues in neurological surgery. Results: A total of 2724 screws were placed in 127 patients. All case demographics are summarized in Table 1. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Show more. Pitfall: Unstable injuries. 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. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Accuracy of C2 pedicle screw placement using the anatomic freehand technique. Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). A p < 0.05 was considered statistically significant. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. Five patients had uneventful early postoperative course. The median time to case closure was 56.3 (35.267.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.477.2) months for defendant (surgeon) verdicts (p = 0.117). Wolters Kluwer Health J Neurosurg Spine. Spine 18:18621866, 1993. Spine 15:908912, 1990. 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). The medicolegal landscape of spine surgery: how do surgeons fare? 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. Of note, the award amount for one settlement case was undisclosed. 1). 11. 1. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. were excluded from analysis. Of note, the award amount for one settlement case was undisclosed. Studies have shown that the greatest proportion of malpractice claims in spine surgery are related to procedural error,10,11,14,16,17,19 often resulting in the highest payouts.11,20 For spine surgery, one common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass screws, which occurs in approximately 14%55% of cases using standard techniques and results in neurological injury and/or durotomy in approximately 1%8% of cases.21 Misplaced screws have the potential to cause severe and sometimes permanent neurological deficits, including spinal cord and/or nerve root injury,21 as well as to decrease the stability of the fusion construct, leading to delayed complications related to pseudarthrosis. Statistical analysis: Sankey. Privacy Policy. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. 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. (%), Pseudarthrosis requiring revision surgery. EOS System Courtesy of EOS imaging. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. This site needs JavaScript to work properly. 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. 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. There were no observed cases of screw misplacement outside the pedicle on routine AP and lateral radiographs. Br J Neurosurg. 2012;41(2):6973. Critically revising the article: all authors. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 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. Malpractice litigation and the spine: the NHS perspective on 235 successful claims in England. Reviewed submitted version of manuscript: all authors. Complete degeneration of the upper disc developed in two patients who had spinal stenosis and degenerative scoliosis. 2005;293(21):26092617. It should be used by experienced and qualified surgeons who are aware of the pitfalls associated with its use. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. 2012;37(1):6776. 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. Bydon M, Xu R, Amin AG, Macki M, Kaloostian P, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham TF. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. 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. 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. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. Spinal fusion procedures are increasingly performed each year, with Deyo et al. Orthop Trans 11:99, 1987. 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. Zdeblick 38 also reported an overall arthrodesis rate of 65% in patients without instrumentation, 77% in patients with semirigid fixation, and 95% in patients with a rigid constrained screw-rod system. While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. + 48 696 042 504. 2020;11:38. 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. They both had motor deficits from which 1 patient recovered completely. Quraishi NA, Hammett TC, Todd DB, et al. Accessibility 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. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. Intraoperative pedicle fractures requiring further points of fixation. Defensive medicine in U.S. spine neurosurgery. Likewise, research shows that breaches still occur when these tools are used,33,40 and some studies did not find a difference in pedicle breach rates compared to those with traditional fluoroscopic and freehand techniques.33 Ultimately, misplaced instrumentation is a risk of any spinal fusion surgery, and a thorough discussion of these risks, as well as the alternative management options, is essential to maintain high-quality patient care and to avoid litigation. pedicle screw misplacement malpractice. However, the misplacement of pedicle screws can lead to disastrous complications. Am J Transl Res. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. NCI CPTC Antibody Characterization Program. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. These numbers are in line with the current literature. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. 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. The incidence of screw failure, which can occur despite solid arthrodesis, 7 in the current series was 8% and mainly involved patients with thoracolumbar injury. Scarone P, Vincenzo G, Distefano D, et al. Retrospective Computed Tomography Scan Analysis of Percutaneously Bookshelf 2021 Jul 1;41(Suppl 1):S80-S86. Are We Underestimating the Significance of Pedicle Screw Misplacement 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. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Unilateral nonunion was seen in three patients (2.7%), associated with implant failure in one of the patients. Dalenberg DD, Asher MA, Robinson RG, Jayaraman G: The effect of a stiff spinal implant and its loosening on bone mineral content in canines. Spine 16(8 Suppl):S422427, 1991. 1. Some error has occurred while processing your request. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. 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. The patient had subsequent coronal imbalance and degeneration of the upper disc. Rothberg MB, Class J, Bishop TF, et al. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. However, the highest offer had been a combined $300,000 from the two defendants. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. 25. 2009;10(1):3339. 2022 Jun;8(2):234-241. doi: 10.21037/jss-22-28. 2017;27(4):470475. 9. 15. 2017;31(3):287288. All the operations were done by one surgeon (PK). Morphometric analysis of the proximal thoracic pedicles in Lenke II and IV adolescent idiopathic scoliosis: an evaluation of the feasibility for pedicle screw insertion. Drs. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 35. Ann Thorac Surg. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. Surg Neurol. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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 neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. 2012;7(6):e39237. Plaintiff-awarded cases by US region (left). Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Clin Orthop 115:130139, 1976. 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. The third surgical procedure removed the pedicle screws but left the patient in an unfused state with an unstable spine. Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Rynecki ND, Coban D, Gantz O, et al. 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. 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). Reoperation for Misplaced Pedicle Screws: A Multicenter Retrospec Rovit RL, Simon AS, Drew J, et al. None of these complications resulted in additional surgery or in a significant increase of morbidity. Acquisition of data: Sankey. Spine 14:472476, 1989. Larson AN, Santos ER, Polly DW Jr, Ledonio CG, Sembrano JN, Mielke CH, Guidera KJ. 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. South Med J 62:17, 1969. 2018;29(4):397406. 2019;19(7):12211231. Deyo RA, Mirza SK, Martin BI. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Preparation. 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). Similar to our findings, prior studies have shown that settlements result in lower payouts than cases that are ultimately taken to trial,7,14,15,30 with awards ranging from $125,000 to $9,000,000 compared to $134,000 to more than $38,000,000.7,15 Nevertheless, the true financial toll on spine surgery is largely unknown given that 85% of cases are dismissed or settled out of court, with undisclosed amounts.14 Likewise, substantial time is spent and costs, including legal and administrative, are incurred before judgment, as noted above. 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. Both issues represent the most frequent and highest payouts in spine malpractice claims.10,14,22 While several studies have explored many of the factors related to malpractice claims in spine surgery, the medicolegal impact of misplaced pedicle and/or lateral mass screws has not been directly reported in the literature. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. The average followup was 35 months (range, 1851 months). 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 St Louis, CV Mosby 322327, 1987. Thirty-five (27.56%) had IMP and 18 (14.17%) had SAR. Don't jump in get legal help. 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. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. 18. Unauthorized use of these marks is strictly prohibited. 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. With increasing pedicle screw usage, the number of patients with misplaced screws will likely increase proportionally. Administrative/technical/material support: Mehta, Wang, KD Than. Please try again soon. J Neurosurg Spine. Call Us Now For a Free Consultation | Toll Free: 800.583.8002 | Local: 312.346.0045, Cook County Surgeons Cut Common BIle Duct During Surgery, But Jury Finds for Defendants , Illinois Jury Finds in Favor of Doctor in Gallbladder Surgery that Led to Fatal Bowel Perforation , Debate Over Extent of Eye Damage Following Implant Lens Surgery Leads to $1 Million Verdict in, $75 Million Jury Verdict in Failure to Timely Diagnose Stroke, $18 Million Jury Verdict in Late Diagnosis of Breast Cancer, $300,000 Settlement for Excessive Use of Radiation, Chicago Medical Malpractice Lawyer Kreisman Law Offices Home, Contact Illinois Personal Injury Attorney Kreisman Law Offices. 2016;25(3):716723. Malpractice litigation following spine surgery. Balch CM, Oreskovich MR, Dyrbye LN, et al. 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. 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. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. leg pain. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Patient-specific 3D-printed surgical guides for pedicle screw insertion There were 74 men and 38 women, with a mean age of 47 years (range, 1872 years). J Bone Joint Surg 62A:13021307, 1980. MeSH Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. In addition, studies have shown that over 85% of malpractice claims are either dismissed or settled out of court,14 which likely results in a high degree of underreporting. Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Eur Spine J. West et al 33 also reported a 29% complication rate for the first 50 patients and a 26% complication rate for the last 74 patients. 30. Guillain A, Moncany AH, Hamel O, et al. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. Your message has been successfully sent to your colleague. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. 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. Pedicle screw accuracy in thoracolumbar fractures- is routine shooting in valdosta leaves one dead PLoS One. 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. 28. Spine J. 22. Materials and Methods Sixty . J Spinal Disord Tech. Pullout strength of misplaced pedicle screws in the thoracic and lumbar Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. Over 40% of patients had screws with either some/major concern. 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. This step in implant evolution was inevitable, because prior phases of implant development did not control each plane of motion segment stress. 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.