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NFlex Dynamic Stabilization System : Two-Year Clinical Outcomes of Multi-Center Study
Coe, Jeffrey D.,Kitchel, Scott H.,Meisel, Hans Jorg,Wingo, Charles H.,Lee, Soo-Eon,Jahng, Tae-Ahn The Korean Neurosurgical Society 2012 Journal of Korean neurosurgical society Vol.51 No.6
Objective : Pedicle-based dynamic stabilization systems, in which semi-rigid rods or cords are used to restrict or control spinal segmental motion, aim to reduce or eliminate the drawbacks associated with rigid fusion. In this study, we analyzed the two-year clinical outcomes of patients treated with the NFlex (Synthes Spine, Inc.), a pedicle-based dynamic stabilization system. Methods : Five sites participated in a retrospective study of 72 consecutive patients who underwent NFlex stabilization. Of these 72 patients, 65 were available for 2-year follow-up. Patients were included based on the presence of degenerative disc disease (29 patients), degenerative spondylolisthesis (16 patients), lumbar stenosis (9 patients), adjacent segment degeneration (6 patients), and degenerative lumbar scoliosis (5 patients). The clinical outcome measures at each assessment were Visual Analogue Scale (VAS) to measure back pain, and Oswestry Disability Index (ODI) to measure functional status. Radiographic assessments included evidence of instrumentation failure or screw loosening. Results : Sixty-five patients (26 men and 39 women) with a mean age of 54.5 years were included. Mean follow-up was 25.6 months. The mean VAS score improved from 8.1 preoperatively to 3.8 postoperatively, representing a 53% improvement, and the ODI score from 44.5 to 21.8, representing a 51% improvement. Improvements in pain and disability scores were statistically significant. Three implant-related complications were observed. Conclusion : Posterior pedicle-based dynamic stabilization using the NFlex system seems effective in improving pain and functional scores, with sustained clinical improvement after two years. With appropriate patient selection, it may be considered an effective alternative to rigid fusion.
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Stefan Schwan,C. Ludtka,A. Friedmann,T. Mendel,H. J. Meisel,A. Heilmann,I. Kaden,F. Goehre 한국조직공학과 재생의학회 2017 조직공학과 재생의학 Vol.14 No.6
Autologous disc cell transplantation (ADCT) is a cell-based therapy aiming to initiate regeneration of intervertebral disc (IVD) tissue, but little is known about potential risks. This study aims to investigate the presence of structural phenomena accompanying the transformation process after ADCT treatment in IVD disease. Structural phenomena of ADCT-treated patients (Group 1, n = 10) with recurrent disc herniation were compared to conventionally-treated patients with recurrent herniation (Group 2, n = 10) and patients with a first-time herniation (Group 3, n = 10). For ethical reasons, a control group of ADCT patients who did not have a recurrent disc herniation was not possible. Tissue samples were obtained via micro-sequestrectomy after disc herniation and analyzed by micro-computed tomography, scanning electron microscopy, energy dispersive spectroscopy, and histology in terms of calcification zones, tissue structure, cell density, cell morphology, and elemental composition. The major differentiator between sample groups was calcium microcrystal formation in all ADCT samples, not found in any of the control group samples, which may indicate disc degradation. The incorporation of mineral particles provided clear contrast between the different materials and chemical analysis of a single particle indicated the presence of magnesium-containing calcium phosphate. As IVD calcification is a primary indicator of disc degeneration, further investigation of ADCT and detailed investigations assessing each patient’s Pfirrmann degeneration grade following herniation is warranted. Structural phenomena unique to ADCT herniation prompt further investigation of the therapy’s mechanisms and its effect on IVD tissue. However, the impossibility of a perfect control group limits the generalizable interpretation of the results.
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Anthony D’Oro,Zorica Buser,Darrel Scott Brodke,박종범,Sangwook Tim Yoon,Jim Aimen Youssef,Hans-Joerg Meisel,Kristen Emmanuel Radcliff,Patrick Hsieh,Jeffrey Chun Wang 대한척추외과학회 2018 Asian Spine Journal Vol.12 No.6
Study Design: Retrospective review. Purpose: To identify the trends in stimulator use, pair those trends with various grafting materials, and determine the influence of stimulators on the risk of revision surgery. Overview of Literature: A large number of studies has reported beneficial effects of electromagnetic energy in healing long bone fractures. However, there are few clinical studies regarding the use of electrical stimulators in spinal fusion. Methods: We used insurance billing codes to identify patients with lumbar disc degeneration who underwent anterior lumbar interbody fusion (ALIF). Comparisons between patients who did and did not receive electrical stimulators following surgery were performed using logistic regression analysis, chi-square test, and odds ratio (OR) analysis. Results: Approximately 19% of the patients (495/2,613) received external stimulators following ALIF surgery. There was a slight increase in stimulator use from 2008 to 2014 (multi-level R 2=0.08, single-level R 2=0.05). Patients who underwent multi-level procedures were more likely to receive stimulators than patients who underwent single-level procedures (p <0.05; OR, 3.72; 95% confidence interval, 3.02–4.57). Grafting options associated with most frequent stimulator use were bone marrow aspirates (BMA) plus autograft or allograft for single-level and allograft alone for multi-level procedures. In both cohorts, patients treated with bone morphogenetic proteins were least likely to receive electrical stimulators (p <0.05). Patients who received stimulation generally had higher reimbursements. Concurrent posterior lumbar fusion (PLF) (ALIF+PLF) increased the likelihood of receiving stimulators (p <0.05). Patients who received electrical stimulators had similar revision rates as those who did not receive stimulation (p >0.05), except those in the multilevel ALIF+PLF cohort, wherein the patients who underwent stimulation had higher rates of revision surgery. Conclusions: Concurrent PLF or multi-level procedures increased patients’ likelihood of receiving stimulators, however, the presence of comorbidities did not. Patients who received BMA plus autograft or allograft were more likely to receive stimulation. Patients with and without bone stimulators had similar rates of revision surgery.
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