Spinal fusion in the United States: analysis of trends from 1998 to 2008. The medicolegal landscape of spine surgery: how do surgeons fare? 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. You may be trying to access this site from a secured browser on the server. All Rights Reserved. sharing sensitive information, make sure youre on a federal 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. Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. 1. 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. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. In several of the studies in the spinal literature, the contention that instrumentation improves arthrodesis rates, considering that nonunion contributes to a poor outcome in spinal arthrodesis is favored. Statistical analysis: Sankey. 2011;213(5):657667. Disclaimer. Epub 2022 Oct 29. General complications were considered those developing during and after surgery that were not directly related to instrumentation. Several studies reveal that fusion rates increase when rigid internal fixation is used, 14,20,21,33,38 and that by using pedicle screws and plates or rods for stabilization, spinal arthrodesis can be limited to the disease segments. However, the highest offer had been a combined $300,000 from the two defendants. Breakage of a divergent screw of a Chopin block at the lumbosacral area was seen 3 months after surgery. 32. Clin Orthop 203:126134, 1986. These numbers are in line with the current literature. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Clinical Orthopaedics and Related Research411:86-94, June 2003. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. 2018;28(2):186193. 10. Screw Malposition: Are There Long-term Repercussions to Malposition of Pedicle Screws? 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 Autor de la entrada Por ; Fecha de la entrada austin brown musician; matrix toners for bleached hair . Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine. Orthop Trans 11:99, 1987. 20th Annual Spine, Orthopedic & Pain Management-Driven ASC Conference, 8th Annual Health IT + Digital Health + RCM Conference, 29th Annual Meeting - The Business & Operations of ASCs, The issues spine surgeons are advocating for outside of the operating room, Centinel Spine is now covered by all major payers, What's next for SI joint fusion? It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Careers. 5. These risks can be minimized by the judicious use of instrumentation by experienced surgeons for specific indications as supported by the literature. This was followed by pseudarthrosis requiring revision surgery, present in 14.3% (n = 3) and 14.9% (n = 7) of plaintiff- and defendant-awarded cases, respectively (p = 0.99). Nottmeier EW, Seemer W, Young PM. 2017;27(4):470475. Defensive medicine in neurosurgery: the Canadian experience. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. J Bone Joint Surg 61A:201207, 1979. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. . Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. 19. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. One hundred four of the 112 patients had a posterior procedure. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. 4. Clin Orthop 203:717, 1986. J Neurosurg Spine. 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. 8,24,25,32. 2,24,28,36. J Neurosurg Spine. Per-patient analysis reveals more concerning numbers toward screw misplacement. Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Quraishi NA, Hammett TC, Todd DB, et al. 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. Pedicle screw insertion techniques: an update and review of the (PDF) Accuracy of pedicle screw placement in the lumbosacral spine Disclosures Dr. Karikari is a consultant for NuVasive, Globus, Johnson & Johnson, and DePuy and receives a spine fellowship fund from NuVasive. Fortunately, most of the complications were minor and transient. Din RS, Yan SC, Cote DJ, et al. 3,4,9,29,34 In addition, developments in surgical technique and implant design have decreased operative risk and implant-related complications. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction HHS Vulnerability Disclosure, Help Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. PMC 21. 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. to maintaining your privacy and will not share your personal information without Problems at the junctions of the instrumented spine were seen in five patients (4.5%). leg pain. J Bone Joint Surg 45A:11591170, 1963. Results. Seven hundred sixty-three screws were inserted in 138 patients. 7. 26. 2014;20(2):196203. Balch CM, Oreskovich MR, Dyrbye LN, et al. Unable to load your collection due to an error, Unable to load your delegates due to an error. The total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. Lumbar Spine Surgery. Spine 6:263267, 1981. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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. Spine Deform. Drafting the article: Sankey. 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. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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. GraphPad Prism version 6.01 for Windows was used for all descriptive analyses (GraphPad Software). 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. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. Abstract BACKGROUND CONTEXT Surgeons have increasingly adopted robotic-assisted lumbar spinal fusion due to indications that robotic-assisted surgery can reduce pedicle screw misplacement. 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. PLoS One. Malpractice litigation following spine surgery. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Pedicle screw insertion in the thoracolumbar spine. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 2018;18(2):209215. Segal J. Pedicle screw instrumentation is widely used for the stabilization of the subaxial cervical, thoracic, and lumbar spine. Med Econ. Background The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. shooting in valdosta leaves one dead Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted 2011;365(7):629636. Despite these failures, solid spinal arthrodesis was obtained in all patients. Epstein NE. These complications may have resulted from powerful bending movement acting on the screw at its entry point to the bone. Please enable scripts and reload this page. Most of these complications were minor and with the exception of two misplaced screws, did not contribute to the occurrence of neurologic impairment or severe pain. In the current series, including general complications, only 48 patients (43%) had no notable complication and the remaining 64 patients (57%) had one or more complications. J Neurosurg Spine. Objective: Rajasekaran S, Bhushan M, Aiyer S, et al. 2018;29(4):397406. J Spine Surg. J Bone Joint Surg 62A:13021307, 1980. 2021 Jul 1;41(Suppl 1):S80-S86. 18. Deyo RA, Mirza SK, Martin BI. Spine 24:23522357, 1999. 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. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. Kreisman Law Offices has been handling Illinois surgical error lawsuits for individuals and families for more than 35 years in and around Chicago, Cook County and surrounding areas, including Batavia, Bellwood, Deerfield, Evanston, Franklin Park, and Lansing. 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. 22. 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. Sethi MK, Obremskey WT, Natividad H, et al. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 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, we did not observe any screw breakage in patients with a degenerative lumbar spine, and the absence of broken screws in this series is because arthrodesis in almost all patients occurred in situ. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Spine 13:696706, 1988. Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. Copyright © 2023 Becker's Healthcare. Spine 8:970981, 1996. Epub 2021 Aug 28. Of note, the award amount for one settlement case was undisclosed. The medicolegal impact of misplaced pedicle and lateral mass screws on This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Epub 2014 Apr 4. Acta Neurochir (Wien). NCI CPTC Antibody Characterization Program. The third patient, who had central spinal stenosis, was treated by decompression alone. The average followup was 35 months (range, 1851 months). Materials and Methods Sixty . The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. It was firstly introduced by Harrington and Tullos in 1969 and then in late 1980s developed by Roy Camille et al., Louis, and Steffe. However, the misplacement of pedicle screws can lead to disastrous complications. Spine 17:349355, 1992. Eur Spine J. Pullout strength of misplaced pedicle screws in the thoracic and lumbar Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. J Neurosurg. A total of 2724 screws were placed in 127 patients. 15. Agarwal N, Gupta R, Agarwal P, et al. Complications were classified as general, hardware-related, problems associated with the instrumented segments, junctional level problems, and problems related with balance (Table 2). 2019;19(7):12211231. 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. Thoracic pedicle screw placement: Free-hand technique - Bioline 2020;45(2):E111E119. The https:// ensures that you are connecting to the A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. In two patients in the current series, dislodgement of the rods from tulip screws occurred, as reported originally by Edmunds et al. 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. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. 2013;34(6):699705. In the other patient, L4L5 float arthrodesis was done. Facebook Google Plus Youtube RSS Email. 31. Unauthorized use of these marks is strictly prohibited. Each side was judged separately. Ann Thorac Surg. Five patients had uneventful early postoperative course. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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. Please try again soon. 3. Makhni MC, Park PJ, Jimenez J, et al. 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). 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 misplacement malpractice. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 3. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Medical malpractice in orthopedic surgery: a Westlaw-based demographic analysis. Federal government websites often end in .gov or .mil. and transmitted securely. Delayed open treatment of aortic penetration by a thoracic pedicle (A) Anteroposterior and (B) lateral radiographs show coronal imbalance that developed 4 years after surgery in a 57-year-old woman with L3L4 float fusion. Spine 16:576579, 1991. Critically revising the article: all authors. 2014;75(6):609613. Under the high-low agreement, Drs. 2017;31(3):287288. States were then grouped by US region and case year by 5-year intervals. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? I won't be at the office but I will check my voice mail. Rovit RL, Simon AS, Drew J, et al. 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). Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. 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. Spine (Phila Pa 1976). Examples of both laterally and medially misplaced lumbar pedicle screws are provided in Fig. A TLIF is a surgical procedure that attempts to fuse vertebrae in order to stabilize the patient's spine. Spinal fusion procedures are increasingly performed each year, with Deyo et al. 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%). haroinfather roblox id However, only a few complications were related to a poor clinical outcome. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. Pullout performance comparison of pedicle screws based on cement Jury awards $4.5M over misplaced pedicle screw during spine surgery: 5 things to know Spine Monday, May 7th, 2018 Post Listen Text Size On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. J Bone Joint Surg 54A:11951204, 1972. Friedlander and Bradley will pay half of the $2.25 million. Svider PF, Kovalerchik O, Mauro AC, et al. All the incidental dural tears were repaired immediately and produced no clinical sequelae. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Guillain A, Moncany AH, Hamel O, et al. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. 2018;41(5):e615e620. The patient had subsequent coronal imbalance and degeneration of the upper disc. 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. Neurological outcome and management of pedicle screws - PubMed Clin Orthop 227:1023, 1988. 2. 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. Hadjipavlou A, Enker P, Dupuis P, Katzman S, Silver J: The causes of failure of lumbar transpedicular spinal instrumentation and fusion: A prospective study. 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. One of the common means of doing so is to place a screw into each of two adjacent spinal bones (vertebrae), and then a rod between them. Thus, meaningful efforts to limit the rate of misplaced pedicle and lateral mass screws, such as the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation, should be carefully considered. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. 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. A p < 0.05 was considered statistically significant. Surg Neurol Int. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Conclusion: With pedicle shapes and sizes varying wildly in the scoliotic spine, misplacement of a screwas well as and under- or oversizingare real possibilities in spine surgery. Smith TR, Hulou MM, Yan SC, et al. Schlegel JD, Smith JA, Schleusener RN: Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 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. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. 20. Jena AB, Seabury S, Lakdawalla D, Chandra A. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders, deformities, and trauma. Achieving proper lumbar lordosis, evaluating any preexisting scoliosis, and intraoperative assessment with AP radiographs could prevent balance problems. Can Postoperative Radiographs Accurately Identify Screw Misplacements? The contact form sends information by non-encrypted email, which is not secure. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 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. 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. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Spine 18:983991, 1993. Pedicle screw accuracy in thoracolumbar fractures- is routine postoperative CT scan necessary? It is easier to confuse a jury than convince a judge: the crisis in medical malpractice. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. single homes for sale in lehigh valley, pa single homes for sale in lehigh valley, pa Home Realizacje i porady Bez kategorii single homes for sale in lehigh valley, pa Pedicle screw | definition of pedicle screw by Medical dictionary 16,24,28 Simultaneously, the evolution of the surgical techniques has led to increased procedural safety. Personal consequences of malpractice lawsuits on American surgeons. The defendants explanation provided an explanation for why Nyquists foot drop did not resolve after the misplaced screw was removed and shed doubt on the plaintiffs theory of liability. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. Placement of the pedicle screws in the thoracolumbar and lumbar spine is a technically demanding procedure. Cases involving wrong-level or -side surgery, implant malfunction, or other misplaced spinal instrumentation (e.g., interbody cases, rods, surgical instruments, etc.) 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.
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