DOI QR코드

DOI QR Code

NFlex Dynamic Stabilization System : Two-Year Clinical Outcomes of Multi-Center Study

  • Coe, Jeffrey D. (Silicon Valley Spine Institute) ;
  • Kitchel, Scott H. (Orthopedic Spine Associates) ;
  • Meisel, Hans Jorg (BG-Clinic Bergmannstrost) ;
  • Wingo, Charles H. (Tallahassee Orthopedic Clinic) ;
  • Lee, Soo-Eon (Department of Neurosurgery, Seoul National University College of Medicine) ;
  • Jahng, Tae-Ahn (Department of Neurosurgery, Seoul National University College of Medicine)
  • 투고 : 2011.12.20
  • 심사 : 2012.06.13
  • 발행 : 2012.06.28

초록

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.

키워드

참고문헌

  1. Acosta FL, Christensen FB, Coe JD, Jahng TA, Kitchel SH, Meiser HJ, et al. : Early clinical and radiograhic results of NFix II posterior dynamic stabilization system. SAS Journal 2 : 69-75, 2008 https://doi.org/10.1016/S1935-9810(08)70021-5
  2. Bastian L, Lange U, Knop C, Tusch G, Blauth M : Evaluation of the mobility of adjacent segments after posterior thoracolumbar fixation: a biomechanical study. Eur Spine J 10 : 295-300, 2001 https://doi.org/10.1007/s005860100278
  3. Bono CM, Kadaba M, Vaccaro AR : Posterior pedicle fixation-based dynamic stabilization devices for the treatment of degenerative diseases of the lumbar spine. J Spinal Disord Tech 22 : 376-383, 2009 https://doi.org/10.1097/BSD.0b013e31817c6489
  4. Boos N, Webb JK : Pedicle screw fixation in spinal disorders : a European view. Eur Spine J 6 : 2-18, 1997 https://doi.org/10.1007/BF01676569
  5. Chou WY, Hsu CJ, Chang WN, Wong CY : Adjacent segment degeneration after lumbar spinal posterolateral fusion with instrumentation in elderly patients. Arch Orthop Trauma Surg 122 : 39-43, 2002 https://doi.org/10.1007/s004020100314
  6. Crawford NR, Reyes PM, Senoglu M, Yim J : Motion Characteristics of the NFlex Pedicle Screw Based Dynamic Stabilization System : A Human Cadaver. Spine Arthroplasty Society Annual Meeting, Miami USA, 2008
  7. Etebar S, Cahill DW : Risk factors for adjacent-segment failure following lumbar fixation with rigid instrumentation for degenerative instability. J Neurosurg 90 : 163-169, 1999
  8. Fritzell P, Hagg O, Wessberg P, Nordwall A : Chronic low back pain and fusion : a comparison of three surgical techniques : a prospective multicenter randomized study from the Swedish lumbar spine study group. Spine (Phila Pa 1976) 27 : 1131-1141, 2002 https://doi.org/10.1097/00007632-200206010-00002
  9. Fritzell P, Hagg O, Nordwall A : Complications in lumbar fusion surgery for chronic low back pain : comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group. Eur Spine J 12 : 178-189, 2003
  10. Galbusera F, Bellini CM, Anasetti F, Ciavarro C, Lovi A, Brayda-Bruno M : Rigid and flexible spinal stabilization devices : a biomechanical comparison. Med Eng Phys 33 : 490-496, 2011 https://doi.org/10.1016/j.medengphy.2010.11.018
  11. Grob D, Benini A, Junge A, Mannion AF : Clinical experience with the Dynesys semirigid fixation system for the lumbar spine : surgical and patient-oriented outcome in 50 cases after an average of 2 years. Spine (Phila Pa 1976) 30 : 324-331, 2005 https://doi.org/10.1097/01.brs.0000152584.46266.25
  12. Guigui P, Wodecki P, Bizot P, Lambert P, Chaumeil G, Deburge A : [Long-term influence of associated arthrodesis on adjacent segments in the treatment of lumbar stenosis : a series of 127 cases with 9-year follow-up]. Rev Chir Orthop Reparatrice Appar Mot 86 : 546-557, 2000
  13. Highsmith JM, Tumialán LM, Rodts GE Jr : Flexible rods and the case for dynamic stabilization. Neurosurg Focus 22 : E11, 2007
  14. Hilibrand AS, Robbins M : Adjacent segment degeneration and adjacent segment disease : the consequences of spinal fusion? Spine J 4 : 190S-194S, 2004 https://doi.org/10.1016/j.spinee.2004.07.007
  15. Khoueir P, Kim KA, Wang MY : Classification of posterior dynamic stabilization devices. Neurosurg Focus 22 : E3, 2007
  16. Lee SE, Park SB, Jahng TA, Chung CK, Kim HJ : Clinical experience of the dynamic stabilization system for the degenerative spine disease. J Korean Neurosurg Soc 43 : 221-226, 2008 https://doi.org/10.3340/jkns.2008.43.5.221
  17. Lehmann TR, Spratt KF, Tozzi JE, Weinstein JN, Reinarz SJ, el-Khoury GY, et al. : Long-term follow-up of lower lumbar fusion patients. Spine (Phila Pa 1976) 12 : 97-104, 1987 https://doi.org/10.1097/00007632-198703000-00004
  18. Markwalder TM, Wenger M : Adjacent-segment morbidity. J Neurosurg 96 : 139-140, 2002
  19. Mulholland RC, Sengupta DK : Rationale, principles and experimental evaluation of the concept of soft stabilization. Eur Spine J 11 : S198-S205, 2002
  20. Putzier M, Schneider SV, Funk JF, Tohtz SW, Perka C : The surgical treatment of the lumbar disc prolapse : nucleotomy with additional transpedicular dynamic stabilization versus nucleotomy alone. Spine (Phila Pa 1976) 30 : E109-E114, 2005 https://doi.org/10.1097/01.brs.0000154630.79887.ef
  21. Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, et al. : Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 5 : correlation between radiographic and functional outcome. J Neurosurg Spine 2 : 658-661, 2005 https://doi.org/10.3171/spi.2005.2.6.0658
  22. Reyes-Sanchez A, Zarate-Kalfopulos B, Ramirez-Mora I, Rosales-Olivarez LM, Alpizar-Aguirre A, Sanchez-Bringas G : Posterior dynamic stabilization of the lumbar spine with the Accuflex rod system as a stand-alone device : experience in 20 patients with 2-year follow-up. Eur Spine J 19 : 2164-2170, 2010 https://doi.org/10.1007/s00586-010-1417-7
  23. Schnake KJ, Schaeren S, Jeanneret B : Dynamic stabilization in addition to decompression for lumbar spinal stenosis with degenerative spondylolisthesis. Spine (Phila Pa 1976) 31 : 442-449, 2006 https://doi.org/10.1097/01.brs.0000200092.49001.6e
  24. Schwarzenbach O, Berlemann U, Stoll TM, Dubois G : Posterior dynamic stabilization systems : DYNESYS. Orthop Clin North Am 36 : 363-372, 2005 https://doi.org/10.1016/j.ocl.2005.03.001
  25. Sengupta DK, Mulholland RC : Fulcrum assisted soft stabilization system : a new concept in the surgical treatment of degenerative low back pain. Spine (Phila Pa 1976) 30 : 1019-1029; discussion 1030, 2005 https://doi.org/10.1097/01.brs.0000160986.39171.4d
  26. Stoffel M, Behr M, Reinke A, Stüer C, Ringel F, Meyer B : Pedicle screw-based dynamic stabilization of the thoracolumbar spine with the Cosmic-system : a prospective observation. Acta Neurochir (Wien) 152 : 835-843, 2010 https://doi.org/10.1007/s00701-009-0583-z
  27. Stoll TM, Dubois G, Schwarzenbach O : The dynamic neutralization system for the spine : a multi-center study of a novel non-fusion system. Eur Spine J 11 : S170-S178, 2002
  28. Wallach CJ, Teng AL, Wang JC. NFlex in Yue JJ, Bertagnoli R, McAfee PC, An HS (eds) : Motion preservation surgery of the spine. Philadelphia : Saunders, 2008, pp505-510
  29. Welch WC, Cheng BC, Awad TE, Davis R, Maxwell JH, Delamarter R, et al. : Clinical outcomes of the Dynesys dynamic neutralization system : 1-year preliminary results. Neurosurg Focus 22 : E8, 2007

피인용 문헌

  1. Dynamic Stabilization for Challenging Lumbar Degenerative Diseases of the Spine: A Review of the Literature vol.2013, pp.None, 2013, https://doi.org/10.1155/2013/753470
  2. Reoperation for Lumbar Canal Stenosis : A 75 Patient Comparative Study vol.22, pp.12, 2012, https://doi.org/10.7887/jcns.22.934
  3. Additional decompression at adjacent segments leads to adjacent segment degeneration after PLIF vol.22, pp.8, 2012, https://doi.org/10.1007/s00586-013-2694-8
  4. Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial vol.15, pp.None, 2012, https://doi.org/10.1186/1471-2474-15-294
  5. COMPARATIVE STUDY ON THE TREATMENT OF DISC HERNIATIONS vol.15, pp.4, 2016, https://doi.org/10.1590/s1808-185120161504146381
  6. Pathoanatomic Risk Factors for Instability and Adjacent Segment Disease in Lumbar Spine: How to Use Topping Off? vol.2017, pp.None, 2017, https://doi.org/10.1155/2017/2964529
  7. Biomechanical effects of hybrid stabilization on the risk of proximal adjacent-segment degeneration following lumbar spinal fusion using an interspinous device or a pedicle screw-based dynamic fixator vol.27, pp.6, 2012, https://doi.org/10.3171/2017.3.spine161169
  8. Biomechanical effects of hybrid stabilization on the risk of proximal adjacent-segment degeneration following lumbar spinal fusion using an interspinous device or a pedicle screw-based dynamic fixator vol.27, pp.6, 2012, https://doi.org/10.3171/2017.3.spine161169
  9. Does the Addition of a Dynamic Pedicle Screw to a Fusion Segment Prevent Adjacent Segment Pathology in the Lumbar Spine? vol.11, pp.5, 2012, https://doi.org/10.4184/asj.2017.11.5.715
  10. Comparison between topping-off technology and posterior lumbar interbody fusion in the treatment of chronic low back pain : A meta-analysis vol.99, pp.5, 2012, https://doi.org/10.1097/md.0000000000018885
  11. Dynamic Stabilization Surgery in Patients with Spinal Stenosis : Long-term Outcomes and the Future vol.46, pp.16, 2012, https://doi.org/10.1097/brs.0000000000004049