Spine 14:472476, 1989. 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. What can spine surgeons do to improve patient care and avoid medical negligence suits? A total of 69 patients (mean age, 67.416 . Mason A, Paulsen R, Babuska JM, et al. 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. 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. Spine Deform. J Spine Surg. Presse Med 78:14471448, 1970. Segal J. 35. 144 A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Epub 2022 Oct 29. In five patients with thoracolumbar injuries, who were the first treated in the current series, and in four patients with fractures in the lower lumbar spine, two-segment fixation was used. to maintaining your privacy and will not share your personal information without Conception and design: Sankey, KD Than. 2021 Jul 1;41(Suppl 1):S80-S86. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. 1. Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. 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. INCLUDE WHEN CITING DOI: 10.3171/2020.8.FOCUS20600. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . 2022 Sep 15;14(9):6323-6331. eCollection 2022. 2012;21(suppl 2):S196S199. 2018;18(2):209215. 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. Patient safety: disclosure of medical errors and risk mitigation. Results. Am J Otolaryngol. 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. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. The jury found the defendants liable and allocated 75 percent of the fault to Dr. Friedlander and 25 percent to Dr. Bradley. 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. Nahed BV, Babu MA, Smith TR, Heary RF. 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). Several limitations should be carefully considered when interpreting our results. Health Aff (Millwood). 2018;43(14):984990. Int Orthop 20:3542, 1996. Pedicle screw | definition of pedicle screw by Medical dictionary Rajasekaran S, Bhushan M, Aiyer S, et al. Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Weinstein JN, Spratt KF, Spengler D, Brick C, Reid S: Spinal pedicle fixation: Reliability and validity of roentgenogram-based assessment and surgical factors on successful screw placement. 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 six of these patients with injuries at the thoracolumbar area (four patients with bent screws and two patients with broken screws), the loss of correction ranged from 3 to 4.5 without change of anatomic reduction (Fig 1). J Neurosurg. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Spine 6:263267, 1981. (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. Neurosurgical practice liability: relative risk by procedure type. 2016;25(3):716723. Also notable, only one claim reported the use of intraoperative CT and was ultimately ruled in favor of the defendant. In situ spine arthrodesis permits load sharing by the vertebral bodies, preventing fatigue failure of the implant. 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. Careers. Misplacement of Pedicle Screws Leads to Years of Pain and Opioid Addiction Laryngoscope. Using Low-Dose, Biplanar Imaging to Reduce Screw Misplacement The https:// ensures that you are connecting to the 2018;27(9):23392347. J Neurosurg Spine. 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. Overall reported screw misplacement is low, but it does not reflect the potential impact on patient morbidity. 2020;162(6):13791387. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Spine 16(8 Suppl):S422427, 1991. Please do not include any confidential or sensitive information in a contact form, text message, or voicemail. Clin Orthop 203:126134, 1986. Percentage of cases per US region (center). 1). Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Edmunds I, Cummine J, Fearnside M: Prevention of dislodgement of Cotrel-Dubousset rods from tulip screws. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. 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). Ultimately, no significant differences were seen in inflation-adjusted award information between plaintiff and defendant (Table 3). Despite this problem, the clinical result was excellent. Mississippi Appellate Court Affirms Medical Malpractice Defense Verdict 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. 30. J Bone Joint Surg 54A:11951204, 1972. 2011;24(1):1519. 2020;45(2):E111E119. J Pediatr Orthop. 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 The third patient, who had central spinal stenosis, was treated by decompression alone. J Neurosurg. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. Accessibility 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 total number of reoperations for MPS and patient clinical data were obtained from medical records at each hospital. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. 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. Louw JA, Dommissee GF, Roos MF: Spinal stenosis following anterior spinal fusion. 22. 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. 2011;213(5):657667. Clin Orthop 203:7598, 1986. 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. A p < 0.05 was considered statistically significant. 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. Spine 13:952953, 1988. The defense pointed to the lack of evidence that the screw had ever come into contact with the L5 nerve root. 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. 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. Balch CM, Oreskovich MR, Dyrbye LN, 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. General complications were considered those developing during and after surgery that were not directly related to instrumentation. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted 70% of Pedicle Screws are misplaced - orthostreams.com 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. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. your express consent. 2021 Nov 26;22(1):986. doi: 10.1186/s12891-021-04860-y. 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. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Rynecki ND, Coban D, Gantz O, et al. Plaintiff's expert was prepared to testify at trial that these complaints are characteristic of a malpositioned screw impinging upon a neural structure. pedicle screw: A rigid surgical implant used to stabilize adjacent spinal segments in spinal fusion surgery. Defensive medicine: a culprit in spiking healthcare costs. Complications and Problems Related to Pedicle Screw Fixation - LWW 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). The accuracy of pedicle screw placement using intraoperative image guidance systems. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. 32. Sarwahi V, Ayan S, Amaral T, Wendolowski S, Gecelter R, Lo Y, Thornhill B. Spine Deform. Pedicle screw insertion techniques: an update and review of the 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. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. 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. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. 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 standard imaging technique for pedicle screw insertion is two-dimensional images obtained from C-arm-type X-ray fluoroscopy. 15. 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. Spine 18:983991, 1993. Some error has occurred while processing your request. The physician ordered an MRI of the lumbar spine which showed that the screws had been misplaced and were puncturing the patient's lumbar nerves. Malpractice liability and defensive medicine: a national survey of neurosurgeons. Agarwal N, Gupta R, Agarwal P, et al. Accuracy and workflow of navigated spinal instrumentation with the mobile AIRO CT scanner. Cotrel Y, Dubousset J, Guillaumat M: New universal instrumentation in spinal surgery. An official website of the United States government. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. Neurosurgery. In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. Dr. Goodwin has received grants from the Burroughs Wellcome Fund, North Carolina Spine Society, and Robert Wood Johnson Harold Amos Medical Faculty Development Program and the NIH/NINDS K12 NRCDP Physician Scientist Award. Please enable it to take advantage of the complete set of features! Lumbosacral pedicle screw placement using a fluoroscopic pedicle axis Brodsky AE: Post-laminectomy and post-fusion stenosis of the lumbar spine. 2014;174(11):18671868. Intraoperative and postoperative complications were recorded by the authors and the results were evaluated by an independent observer. 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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. JAMA Intern Med. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. 2 One of the first obstacles regarding . Eur Spine J. Lumbar Spine Surgery. 6 St Louis, CV Mosby 322327, 1987. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 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. 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. Three-dimensional printing versus freehand surgical techniques in the surgical management of adolescent idiopathic spinal deformity. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. 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). Spine 18:18621866, 1993. 5. Per-patient analysis reveals more concerning numbers toward screw misplacement. The average age of the patients was 47 years and the average followup was 35 months. Wolters Kluwer Health Guillain A, Moncany AH, Hamel O, et al. Dr. Abd-El-Barr is a consultant for Spineology. The patient suffered permanent nerve damage as a result of the puncture. A retrospective review of closed medicolegal cases with verdicts or settlements between 1995 and 2019 was performed using the Westlaw Edge legal research database (Thomson Reuters).7,14,16,23,24 A search of closed federal and state malpractice claims within the Verdicts and Settlements section consisted of the following: spine and surgery and pedicle and screw and fusion and (misplaced or misguided or mispositioned) and surgeon. Inclusion criteria consisted of malpractice claims against surgeons for complications related to misplaced pedicle and/or lateral mass screws. Disc space narrowing was the most common problem after instrumented arthrodesis and was observed in 27 patients (24.1%). Of note, the award amount for one settlement case was undisclosed. Grubb SA, Lipscomb HJ: Results of lumbosacral fusion for degenerative disc disease with and without instrumentation: Two- to five-year follow-up. 24. The intent is to provide relief from pain and nerve damage. and 17.1% of the patients included had at least one screw misplaced. Statistical analysis: Sankey. Defendant-awarded cases by US region (right). PDF Intraoperative biomechanics of lumbar pedicle screw loosening following This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. 1,12,19,22 The largest series of adjacent segment breakdown was reported by Schlegel et al. 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. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? 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. Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. 27. Pedicle screw placement safety with the aid of patient-specific guides in a case series of patients with thoracic scoliosis. All Rights Reserved. This decision must be made on a case-by-case basis at the surgeons and patients discretion after a thorough discussion of the associated risks and benefits of revision surgery. Smith TR, Hulou MM, Yan SC, et al. $ = US$. Plaintiff-awarded cases by US region (left). Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practicea qualitative study. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Scarone P, Vincenzo G, Distefano D, et al. Edwards CC: Spinal screw fixation of the lumbar and sacral spine: Early results treating the first 50 cases. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. 2007;106(6):11081114. Phone/Fax: 30-2810-318361; E-mail: [emailprotected]. Misplaced pedicle and lateral mass screws result in a considerable risk of malpractice litigation against spine surgeons. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. Instead, the defense offered up an alternative explanation for Nyquists foot drop. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. The rate of reoperation for screw misplacement per screw was 0.17%. Re: malpositioned pedicle screw resulting in additional surgery and disability. Spine 6:615619, 1981. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Jury Verdict for Doctor for Screw Allegedly Misplaced During Lumbar Therefore, when instrumentation is to be used, the benefits must outweigh the risks.
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