31. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Litigation resulted in average payouts of $1,204,422 $753,832 between 1995 and 2019, when adjusted for inflation. 7. Pedicle Screw Insertion in Spondylitis Tuberculosis | ORR 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. Facebook Google Plus Youtube RSS Email. leg pain. Spine (Phila Pa 1976). Results: Nahed BV, Babu MA, Smith TR, Heary RF. However, the misplacement of pedicle screws can lead to disastrous complications because of the close proximity to neural tissue and the surrounding vessels, although rare, serious complications have been reported, such as dural tear, nerve-root irritation, neural injury . [] The accuracy for free-hand screw placement technique varies from 69% to 94%. 26 They support that after a lengthy symptom-free period, segments next to a fused segment can break down and the segment next to the adjacent segment is almost as likely to break down as the adjacent segment. J Neurosurg Spine. Spine Deform. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Surg Neurol. Additional survey data have shown that 50% of physicians exhibit at least a temporary loss of self-esteem after a malpractice claim, and at least 25% experience depression.22 As stated above, the average neurosurgeon spends 27.2% of his or her entire career in an open malpractice claim,10 and each case can take an average of 5.1, 5.0, and 3.4 years for defendant verdicts, plaintiff rulings, and settlements, respectively.7,15 Likewise, neurosurgeons have a higher risk than practitioners in other specialties of being named in multiple malpractice suits given the particularly high-risk nature of the specialty.10 Even when found in favor of the defendant (surgeon), each case ultimately takes a substantial emotional and financial toll on the physician(s) involved. Surg Neurol Int. As part of the surgery, Dr. Taras Masnyk inserted four metal screws into the plaintiffs spine. Rothberg MB, Class J, Bishop TF, et al. 2 One of the first obstacles regarding . Three slender patients complained of soft tissue irritation and a bothersome prominence because of the screws bulky profile. sharing sensitive information, make sure youre on a federal 2012;21(suppl 2):S196S199. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. 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. 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. 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. Makhni MC, Park PJ, Jimenez J, et al. Safety and efficacy of pedicle screw placement using intraoperative computed tomography: consecutive series of 1148 pedicle screws. 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. FOIA 39. 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. Spine 19:25842589, 1994. The medical malpractice suit Ayala v. Friedlander, M.D., claimed that a March 2011 lumbar fusion surgery performed by neurosurgeon Marvin Friedlander, MD, and orthopedic spine surgeon Douglas Bradley, MD, strayed from the accepted standards of care because a pedicle screw was placed in the wrong location. Epstein NE. Epub 2022 Oct 29. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. All case demographics are summarized in Table 1. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. Feb. 16, 2021 Accurate placement of pedicle screws is key to avoiding the potential complications of spinal fusion surgery and improving overall spinal fixation. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. Neurological outcome and management of pedicle screws - PubMed Guzek RH, Mitchell SL, Krakow AR, Harshavardhana NS, Sarkissian EJ, Flynn JM. Epstein NE. J Neurosurg 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). For more information, please refer to our Privacy Policy. 14. 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. pedicle screw misplacement malpractice. Pedicle screw insertions are commonly used for posterior fixation to treat various spine disorders. Unable to load your collection due to an error, Unable to load your delegates due to an error. Spine 16:576579, 1991. Median screw misplacement rate was 10% in group A and 13% in group B. Moffatt-Bruce SD, Ferdinand FD, Fann JI. Nottmeier EW, Seemer W, Young PM. J Am Coll Surg. 2006;65(4):416421. Harris RI, Wiley JJ: Acquired spondylolysis as a sequel to spine fusion. Pedicle screw replacement in spinal surgery - The MDU 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 (Phila Pa 1976). 3). 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). Malpractice risk according to physician specialty. 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). 25. Amount awarded to plaintiffs by US region, adjusted for inflation as of April 2020. Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Patient Suffers Permanent Nerve Damage From Spinal Surgery 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. Retrospective Computed Tomography Scan Analysis of Percutaneously The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). The majority of plaintiffs were male (n = 44, 64.7%), and the median age among all cases was 46 years (range 3757 years). Med Econ. Todd NV. Mukherjee S, Pringle C, Crocker M. A nine-year review of medicolegal claims in neurosurgery. Two patients had an acute infection develop for which they required operative intervention with irrigation and debridement. Intraoperative pedicle fractures requiring further points of fixation. Spine 6:615619, 1981. Pedicle screw placement: Robotic assistance for greater precision A.J. 2018;83(5):9971006. Long spine fixation was necessary for patients with tuberculous spondylitis and metastatic disease. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. What can spine surgeons do to improve patient care and avoid medical negligence suits? A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Reviewed submitted version of manuscript: all authors. 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. It should be used by experienced and qualified surgeons who are familiar with the pitfalls associated with its use. Retrospective analysis of reasons and revision strategy for failed thoracolumbar fracture surgery by posterior approach: a series of 31 cases. Medical malpractice litigation has made a significant impact on spine surgery, with many spine surgeons avoiding complex cases or practicing other defensive medicine tactics in an effort to avoid being sued.5 Moreover, the majority of neurosurgeons spend more than 10% of their annual revenue on malpractice insurance,1,14 and the excessive financial risk of litigation is even leading some insurers to no longer offer coverage to spine surgeons.19 A 2011 study in the New England Journal of Medicine found that 19.1% of neurosurgeons are named as a defendant in a malpractice suit each year (highest of any specialty).12 Moreover, 88% of physicians in high-risk specialties, like neurosurgery, are involved in a lawsuit by age 45, increasing to a concerning 99% by 65 years of age.12 Such litigation places a substantial financial, temporal, and emotional burden on physicians in high-risk specialties, with studies showing that up to 72% of neurosurgeons1 admitted that their fear of litigation significantly influenced their practice,25 with many avoiding high-risk patients altogether.1 Similarly, Nahed et al. Clin Orthop 203:4553, 1986. Spine 13:696706, 1988. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. Malpractice litigation following spine surgery. 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 practice liability: relative risk by procedure type. Spine 17:349355, 1992. 1 To be effective, the pedicle screw constructs must withstand intraoperative loading and physiological forces due to daily postoperative activities. 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. $ = US$; MW = Midwest; NE = Northeast; SE = Southeast; SW = Southwest; W = West. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. Once the spine is exposed, the appropriate levels of fixation are confirmed with the image intensifier. Spine 14:472476, 1989. 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Thu, May 27th, 2021. 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. Pullout strength of misplaced pedicle screws in the thoracic and lumbar The https:// ensures that you are connecting to the On April 6, a Union County, N.J., jury awarded a plaintiff $4.5 million over a botched spine surgery. Minimizing Pedicle Screw Pullout Risks: A Detailed Biomechan Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York State, 1999 through 2003. 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. This retrospective study analyzes the complications and the problems developed during and after pedicle screw fixation in patients with spinal disorders and trauma. Nayar G, Blizzard DJ, Wang TY, et al. 15. The rate of medical complications was 8%. 2012;89(10):7071. A total of 69 patients (mean age, 67.416 . 6 Zucherman J, Hsu K, Picetti III G, et al: Clinical efficacy of spinal instrumentation in lumbar degenerative disc disease. (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. single homes for sale in lehigh valley, pa Drafting the article: Sankey. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Pedicle screw placement accuracy impact and comparison between grading Spine 16(8 Suppl):S455458, 1991. 27. 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. Eur Spine J. 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. The aim of this study is to evaluate the accuracy of pedicle screw insertion in spondylitis tuberculosis kyphosis correction using a freehand technique. 9. In their meta-analysis of nine randomized controlled trials, Li et al. 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. A Cotrel-Dubousset spinal system (Medtronic Sofamor Danek, Memphis, TN) was used in all patients and the total number of screws used was 658. Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. Risk factor analysis showed smaller Cobb angles increased likelihood of all screws being AP. Open lumbar pedicle screw technique - Operative Neurosurgery 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. When adjusted for inflation, these values increased to $1,330,201 $882,023 versus $970,832 $381,619, respectively (p = 0.32; Fig. Ahmadi SA, Sadat H, Scheufler KM, et al. Screw misplacement. The intent is to provide relief from pain and nerve damage. Copyright 2023 Becker's Healthcare. 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. This demonstrates technical ability but does not represent the impact of screw misplacement on individual patients. laterally placed screws and the azygous vein on the right (T5-T11). 2016;25(3):716723. Study design: Cookie Policy. This site needs JavaScript to work properly. Guillain A, Moncany AH, Hamel O, et al. Erwin WD, Dickson JH, Harrington PR: Clinical review of patients with broken Harrington rods. However, the defendant doctor maintained that Nyquists foot drop was not caused by the misplaced screw. N Engl J Med. 13 Whitecloud et al 35 reported 15% neurologic complications, 5% being caused by incorrect screw placement. From the *Department of Orthopaedic Surgery, University of Crete Medical School, Heraklion, Greece; and the **First Department of Orthopaedics, University of Athens Medical School, Athens, Greece. This patient recovered completely in 6 weeks. Please enable it to take advantage of the complete set of features! Segal J. 2013;123(9):20992103. 30. 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. Department of Neurosurgery, Spine Division, Duke University Medical Center, Durham, North Carolina; and, Malpractice liability and defensive medicine: a national survey of neurosurgeons, Defensive medicine among high-risk specialist physicians in a volatile malpractice environment, Defensive medicine: a culprit in spiking healthcare costs, Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study, Defensive medicine in U.S. spine neurosurgery, Personal consequences of malpractice lawsuits on American surgeons. 1. The last two patients had a T12L1 fracture-dislocation and a L4L5 spondylolytic spondylolisthesis at the site of plug dislodgments. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Submitting a contact form, sending a text message, making a phone call, or leaving a voicemail does not create an attorney-client relationship. The largest inflation-adjusted payout awarded to the plaintiff ($3,372,185) for nerve root injury occurred in a 36-year-old male who had undergone an L4S1 posterior spinal fusion, which resulted in permanent and direct injury to right L5 and S1 nerve roots, with foot drop and radiculopathy. Spine 8:970981, 1996. However, the impact of robotic-assisted spinal fusion on patient outcomes is less clear. 2018;29(4):397406. Studdert DM, Mello MM, Sage WM, et al. 32. Hardware problems were those related to the physical change of metal and screw position. Hsu K, Zucherman JF, White AH: Internal Fixation With Pedicle Screws. Reprint requests to Pavlos Katonis, MD, 99 Minoos & Thenon Street, 71305, Heraklion, Crete, Greece. Steinmann JC, Herkowitz HN: Pseudarthrosis of the spine.