8600 Rockville Pike In 2 patients, misplacement of pedicle screws was recognized intraoperatively and all implants were removed. 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. 3. Spine 19(20 Suppl):2279S2296, 1994. Cerebrospinal fluid fistulas. Results: A total of 2724 screws were placed in 127 patients. Arthrodesis was questionable in eight asymptomatic patients (7.1%). 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. 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. 26. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. National Library of Medicine 33. The purpose of current study was to analyze the complications and problems during and after pedicle screw fixation for various spinal disorders and trauma. Previous biomechanical and clinical studies defining junctional segment problems are lacking and consist mainly of case reports. Another possible cause was the high lateral torques to the entire frame that occurred during tightening of the tulip screw. All Rights Reserved. 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. Patient-specific 3D-printed surgical guides for pedicle screw insertion Pedicle screw insertion - AO Foundation Spine 15:1114, 1990. The pedicle screws judged as misplacement. a Medial minor perforation 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. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. 2012 Feb 1;37(3):E188-94. 2020;11:38. When grouped by US region, most cases occurred in the Northeast (n = 25, 36.8%), followed by the West (n = 15, 22.1%; Fig. * Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. 2018;18(2):209215. 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). However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). Ultimately, no significant differences in case demographics were found between plaintiff and defendant judgments (Table 1). Thus, we are unable to comment on whether all misplaced screws, particularly when asymptomatic, should be revised in an effort to prevent litigation. The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). 2018;41(5):e615e620. For more information, please refer to our Privacy Policy. Accuracy of C2 pedicle screw placement using the anatomic freehand Inaccurate pedicle screw placement is relatively common even when placement is performed under fluoroscopic control. Re: malpositioned pedicle screw resulting in additional surgery and disability. Whitecloud III TS, Butler JC, Cohen JL, Candelora PD: Complications with the variable spinal plating system. Subjects were 10,754 patients (73,777 pedicle screws) who underwent PSF at 11 hospitals over 15 years. 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. Pedicle screw placement is a common procedure. FOIA Patient safety: disclosure of medical errors and risk mitigation. Insuring spinal neurosurgery. 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. 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. Several studies have shown that spine surgery is at the highest risk for litigation among the surgical subspecialties.12,29 The majority of claims are related to technical and procedural errors,29 including misplaced pedicle and/or lateral mass screws. We attribute the 24.1% disc space narrowing in the instrumented segments mainly to the severe injury of the disc and communication of the end plate in burst fractures, which could accelerate the disc degeneration and narrowing. 0 attorneys agreed. 2016;102(2):358362. McLaughlin WM, Donnelley CA, Yu K, Gillinov SM, Tuason DA. Hardware problems were those related to the physical change of metal and screw position. PURPOSE This study aimed to compare rates of perioperative complications between robotic-assisted and conventional . 2017;27(4):470475. Nominal and inflation-adjusted award payouts were higher for trial verdicts than for settlement/arbitration, with a nominal average of $1,140,473 $841,683 versus $788,533 $306,186 awarded to the plaintiff, respectively (p = 0.30). However, this is the first study to evaluate the direct medicolegal impact of misplaced pedicle and lateral mass screws on spine surgery in the US and presents important information that may support the routine use of intraoperative imaging confirmation (via 3D fluoroscopy or intraoperative CT) and/or navigated screw placement (either computer- or robot-assisted) as a potential method to decrease the risk of future litigation during spinal fusion procedures. 2011;306(10):1088. 15. 17. J Neurosurg Spine. You are talking one of the most complicated area of the law. Analysis and interpretation of data: Sankey, TT Than. Med Econ. Spine (Phila Pa 1976). 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. NCI CPTC Antibody Characterization Program. 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. Comparetto, Esq., 727-328-7900, www.florida-malpractice-lawyers.com. Problems in the instrumented segments were considered those occurring from narrowing of the disc space greater than 3 mm, pseudarthrosis, and loss of reduction. 2014;20(6):636643. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). Taylor CL. Moreover, several cases stated that the surgeon used only the anteroposterior or the lateral view, but not both, and the plaintiffs counsel used this information in support of their claim. 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. 2014;21(3):320328. However, the misplacement of pedicle screws can lead to disastrous complications. 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. Descriptive analysis of state and federal spine surgery malpractice litigation in the United States. Johnston II CE, Ashman RB, Baird AM, Allard RN: Effect of spinal construct stiffness on early fusion mass incorporation: Experimental study. Please try again soon. Wolters Kluwer Health (A) Anteroposterior and (B) lateral radiographs taken 2 years after surgery show unilateral pseudarthrosis in a 55-year-old man with spinal stenosis. 2012;89(10):7071. 16. + 48 696 042 504. 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. 20 Tips to Avoid and Handle Problems in the Placement - ScienceDirect Thankfully, most screws are just misplaced by a millimeter or two out the front or are slightly off medially, so they are not doing real damage. The accuracy rate of pedicle screw (PS) placement varies from 85% to 95% in the literature. (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. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Adjusted for age and preoperative Cobb angle, patients with a higher misplacement rate were more likely to have screws . However, 5-10% of those misplaced screws are cause for concern." "To rectify this, we must have access to imaging devices during the procedure. Risk Factors for the Drift Phenomenon in Oarm NavigationAssisted 9. pedicle screw misplacement malpractice Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Zdeblick TA: A prospective randomized study of lumbar fusion: Preliminary results. leg pain. The rate of reoperation for screw misplacement per screw was 0.17%. 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). 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. Spine J. However, following the spinal fusion, Nyquist began to experience foot drop in her right foot. Agarwal N, Gupta R, Agarwal P, et al. 2012;37(1):6776. A high-low agreement is a settlement in which a defendant agrees to pay the plaintiff a minimum recovery in exchange for the plaintiff agreeing to accept a maximum amount regardless of the trial's outcome. 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. Spine 18:23252326, 1993. Spine arthrodesis was evaluated with plain AP and lateral radiographs taken 1 year after surgery. 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. Twenty-one patients (18.8%) had thoracolumbar injuries, and loss of immediate postoperative deformity correction ranged from 1.4 to 4.5. In four of these patients, bent screws occurred at 8 to 10 months after surgery; in three patients, broken screw necks were seen 1 year after surgery and in two patients, tulip screw plug dislodgments were observed at 4 and 6 months postoperatively, respectively. Dr. Abd-El-Barr is a consultant for Spineology. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases.