2017;27(4):470475. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. 2017;42(3):177185. Routine CT scans were taken in all patients. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. 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. Aigner R, Bichlmaier C, Oberkircher L, Knauf T, Knig A, Lechler P, Ruchholtz S, Frink M. BMC Musculoskelet Disord. Please try after some time. 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. 2014 Aug 1;14(8):1702-8. doi: 10.1016/j.spinee.2014.03.044. 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). Unable to load your collection due to an error, Unable to load your delegates due to an error. Cookie Policy. 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. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). 28. Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. 37. EOS System Courtesy of EOS imaging. 2. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Sethi MK, Obremskey WT, Natividad H, et al. Spine 17:834837, 1992. Eur Spine J. (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. Axial lumbar CT scans demonstrating both laterally (right) and medially (left) misplaced pedicle screws, resulting in pedicle and transverse process fractures (A) and canal compromise (A and B). Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. All case demographics are summarized in Table 1. 2013;34(6):699705. All the operations were done by one surgeon (PK). Furthermore, 25 patients (22.3%) reported persistent pain in the iliac crest (donor graft site) for several months, for which they were treated with repeated lidocaine injections and analgesics. Nahed BV, Babu MA, Smith TR, Heary RF. Rajasekaran S, Bhushan M, Aiyer S, et al. 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. A CT scan was taken to try and identify the underlying neurological problem that might be causing the new symptom. Likewise, cases are uploaded on a voluntary basis by state and federal judges and courts, which may lead to selection bias. Pedicle screw fixation is an effective but demanding method to treat various spinal disorders and is associated with a significant complication rate. Spine 18:983991, 1993. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. All these problems were observed only just above the upper instrumentation level and all were observed in patients older than 55 years. 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. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. 2002;27(22):24252430. 15. Mayo Clinic uses the latest robot-assisted technology when indicated to enhance surgical precision in these procedures. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Elsamadicy AA, Sergesketter AR, Frakes MD, Lad SP. J Neurosurg Spine. 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. 2018;18(2):209215. 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. 2020;162(6):13791387. Despite this problem, the clinical result was excellent. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Misplacement rates have been reported to be from 5 to 41% in the lumbar spine and from 3 to 55% in the . As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. 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). 2 One of the first obstacles regarding . Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. 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. Orthop Trans 11:99, 1987. doi: 10.1097/BPO.0000000000001828. + 48 696 042 504. Presse Med 78:14471448, 1970. The median time to case closure was longer for defendant-awarded cases, but this finding was not statistically significant (61.5 vs 56.3 months, p > 0.05). 30. Clin Orthop 115:130139, 1976. 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. In the current series, there were no cases of screw misplacement or vascular or neurologic complications caused by implant application. 24. 19. Hardware problems were those related to the physical change of metal and screw position. However, the misplacement of pedicle screws can lead to disastrous complications. 2016;124(5):15241530. Rev Chir Orthop Reparatrice Appar Mot 62:151160, 1976. Ann R Coll Surg Engl. 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. Malpractice litigation following spine surgery. J Neurosurg Spine. 2018;41(5):e615e620. 2018;83(5):9971006. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Methods: Sub-analysis of adolescent idiopathic scoliotic patients showed no curve or patient characteristic that correlated with IMP or SAR. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. Each case was then carefully screened for relevance and sufficient data. Under this theory of liability, the plaintiff needed to not only establish that she had experienced foot drop, a fact that no one was disputing, but that it was caused by the defendants negligence. Spine 14:472476, 1989. Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). 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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. Defensive medicine: a culprit in spiking healthcare costs. Din RS, Yan SC, Cote DJ, et al. States were then grouped by US region and case year by 5-year intervals. 2021 Jul 1;41(Suppl 1):S80-S86. Your message has been successfully sent to your colleague. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). The intent is to provide relief from pain and nerve damage. (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. A total of 47 (69.1%) cases resulted in a decision for the defendant and 21 (30.9%) for the plaintiff. Results. However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. One of the patients had a late wound infection develop that was treated by radical debridement and removal of instrumentation. Spine (Phila Pa 1976). Junctional problems were recorded as pathologic changes of the adjacent motion segments, just above and below the instrumented and fused segments. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Of note, the award amount for one settlement case was undisclosed. Despite these failures, solid spinal arthrodesis was obtained in all 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. Before 2013;123(9):20992103. Fager CA. 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. were excluded from analysis. Study design: Nyquist had requested the defendants offer, which in retrospect was perhaps a poor decision in light of the Kane County jurys verdict. Hardware-related failures were observed in 12 patients (10.7%). leg pain. This site needs JavaScript to work properly. The remaining two patients had asymptomatic junctional problems develop after two- and three-segment fusions, at the third and fourth postoperative year, respectively. Dr. Abd-El-Barr is a consultant for Spineology. 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. [] Computer-assisted computed tomography (CT) techniques have improved the overall accuracy for pedicle screw placement, and has reduced complication rates. Spine 15:908912, 1990. 1 Although this technique has advantages over open instrumentation, it also presents new challenges and specific complications. 2,24,28,36. At the lumbosacral area, breakage of a divergent screw of a Chopin block occurred on only one side with no loss of correction. Saillant G: Etude anatomique des pedicules vertebraux: Application chirurgicale. As compared to cases in 19952009, those in 20102019 resulted in a significantly higher average nominal payout to plaintiffs ($776,439 $74,460 vs $1,506,000 $385,527, p = 0.028). After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. reported that 69.3% of neurosurgeons who responded to their survey saw every patient as a potential lawsuit.1. 4. PMC (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 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. la crosse police scanner,