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Sandro m.Krieg, nele balser, haiko pape, nico sollmann, lucia albers and bernhard meyer: topping-off technique for stabilization of lumbar degenerative instabilities in 322 patients: https://thejns.Org/doi/abs/10.3171/2019.Sex: 164 females and 158 male patients.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: date that the article was accepted for as the event dates were not provided in the published literature.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Sandro m.Krieg, nele balser, haiko pape, nico sollmann, lucia albers and bernhard meyer: topping-off technique for stabilization of lumbar degenerative instabilities in 322 patients: https://thejns.Org/doi/abs/10.3171/2019.Summary: this series includes the first 322 patients enrolled from 2009 to 2015 at our department.All patients underwent pedicle screw¿based semi-rigid stabilization of the lumbar spine with a polyetheretherketone (peek) rod system (cd horizon legacy peek, medtronic).A retrospective and post hocanalysis of prospectively collected data was performed for these patients, all operated on with this approach in the thoracolumbar spine using sri and the topping-off approach.Between september 2009 and november 2015, 322 patients, 164 (50.9%) women and 158 (49.1%) men, underwent surgery and were enrolled for follow-up investigation.Semi-rigid instrumentation (sri) was introduced to take advantage of the concept of load sharing in surgery for spinal stabilization.The authors investigated a topping-off technique in which interbody fusion is not performed in the uppermost motion segment, thus creating a smooth transition from stabilized to free motion segments.Sri using the topping-off technique also reduces the motion of the adjacent segments, which may reduce the risk of adjacent segment disease (asd), a frequently observed sequela of instrumentation and fusion, but this technique may also increase the possibility of screw loosening (sl).In the present study the authors aimed to systematically evaluate reoperation rates, clinical outcomes, and potential risk factors and incidences of asd and sl for this novel approach.Instrumentation and fusion are still considered the standard of care for the treatment of painful degenerative segmental instability of the lumbar spine.Nonetheless, adjacent segment disease (asd) is a frequently observed sequela of this procedure, often resulting in new symptoms and reduced quality of life for affected patients, which frequently necessitate further surgery.Rates of symptomatic asd are reported to be around 2%¿5.5% per year after lumbar fusion,3,6,21,22 and increased mobility of segments adjacent to the fused levels is considered crucial for predisposing patients to asd.1,6 several attempts have been undertaken to smooth the transition from fused to mobile segments and to diminish the altered biomechanical stress at adjacent segments.While some ap proaches allow for motion in instrumented levels with dynamic stabilization (ds), semi-rigid instrumentation (sri) using the topping-off technique reduces the motion of the adjacent segments while promoting fusion of the lower instrumented segments via load sharing.Sri was introduced primarily because it is conducive to load sharing, which should promote bony fusion.We propose a topping-off technique that retains mobility in the uppermost segment, which enables treatment without an anterior cage by creating a smooth transition from stabilized to free motion segments.Because this method allows movement in the spinal segment without fusion, the transmission of forces will be mainly dependent on the bone-screw interface, leading to higher forces in the transition zone at the bone-screw interface, which may induce side effects such as screw loosening (sl), which differ from common side effects of other methods.Most importantly for this study, only segments requiring fusion were included in the instrumentation, which contrasts with other reports on topping-off techniques.This approach may reduce the rates of postoperative asd or may at least prolong the time to development of asd after surgery.The objective of this study was to evaluate reoperation rates, clinical outcomes, and potential risk fact ors of this novel approach in order to compare the success rates of this treatment in a large, prospectively collected, and post hoc analyzed cohort with the rates reported in the literature for rigid fusion.We also evaluated potential risk factors and incidences of asd and sl.The considered risk factors included age, sex, previous surgery, number of segments, level of surgery, and time since surgery.Patients underwent follow-up in the context of personal appointments at our neurosurgical department and via phone 0.8¿7.0 years) after surgery on average, and 121 patients (37.6%) were lost to follow-up after a mean time of 10.2 ± 14.4 months (range 0.0¿59.6 months) until the last follow-up visit.A total of 201 patients (62.4%) completed the 3-month follow-up by hospital visit and examination.Reported events: 1.Screw revision was necessary postoperatively in 4.4% of patients.(9 out of 201 patients) 2.Overall, 18.8% of patients showed asd, which occurred 26.5 ± 17.6 months (range 1.0¿70.0 months) after surgery (80.7% above, 12.3% below, and 7.0% above and below the operated segment).(38 of 201patients) 3.Additional implant failure occurred in 11.6% of patients after 13.0 ± 14.0 months (range 0.1¿63.0 months) (23 of 201 patients) 4.Screw looseness was registered in 21.1% of patients after 14.9 ± 16.0 months (range 0.5¿70 months) with respect to surgery.(42 of 201 patients) 5.50.9% of patients with asd had re-operation.(19 of 38 patients) 6.48.6% of patients with implant failure had re-operation.(11 of 23 patients) 7.45.3% of patients with sl undergoing further surgery had re-operation (19 of 42 patients).
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