MEDIUM-TERM EFFECTIVENESS OF Waveflex SYSTEM IN TREATMENT OF MULTIPLE LUMBAR DEGENERATIVE DISEASES_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

XUEYoudi ,  WANGDong , DAIWeixiang , MAChao , XIAJihua

Department of Orthopaedics, Xuzhou Central Hospital, Xuzhou Jiangsu, 221000, P. R. China;

Corresponding author：

WANGDong, Email: fyzh_wd@163.com

Keywords：

Lumbar degenerative disease; Semi-rigid internal fixation; Waveflex system; Medium-term effectiveness

DOI：

10.7507/1002-1892.20150239

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Objective To evaluate the medium-term effectiveness of Waveflex system in the treatment of multiple lumbar degenerative diseases. Methods Between May 2010 and July 2012, 26 patients with multiple lumbar degenerative diseases underwent posterior decompression, transforaminal lumbar interbody fusion (TLIF), and internal fixation with Waveflex system. There were 15 males and 11 females, aged 23-65 years (mean, 34.2 years). The disease duration was 9 months to 8 years (median, 3 years and 3 months). The lesion located at L₃-S₁. The visual analogue scale (VAS), Oswestry disability index (ODI), and the short-form 36 health survey scale (SF-36) were used to evaluate the status of clinical recovery, meanwhile the Stauffer-Coventry evaluation standard was used to access the satisfaction at last followup; the disc space height (DSH), intervertebral angle (IVA), and range of motion (ROM) were measured on X-ray film or three-dimensional CT, and the adjacent segment degeneration was classified by Pfirrmann score based on MRI findings. Results All patients obtained primary incision healing without nerve injury, cerebrospinal fluid leakage, or internal fixation failure. All patients were followed up 31-50 months (mean, 40.6 months). The VAS, ODI, and SF-36 scores were significantly improved at 6 months after operation and last follow-up when compared with preoperative ones (P<0.05), but no significant difference was found between at 6 months and last follow-up (P>0.05). According to the StaufferCoventry evaluation standard, the results were excellent in 21 cases, good in 2 cases, moderate in 2 cases, and poor in 1 case, with an excellent and good rate of 88.5% at last follow-up. X-ray films showed that there was no complication of screws pulling-out or fixed rod rupture and displacement. At 7 days, 6 months, and last follow-up, the DSH of adjacent segment was significantly increased (P<0.05), and the ROM of adjacent segment was significantly decreased (P<0.05) when compared with preoperative ones; there was no significant difference in IVA between at pre-and post-operation (P>0.05). According to Brantigan grade for fusion, 19 cases were rated as grade E, 6 cases as grade D, and 1 case as grade C, and the fusion rate was 96%. There was no significant difference in Pfirrmann score between at pre-operation and last follow–up (Z=0.000, P=1.000). Conclusion The Waveflex system combined with TLIF is effective and safe to treat multiple lumbar degenerative diseases during medium-term follow-up.

Citation： XUEYoudi, WANGDong, DAIWeixiang, MAChao, XIAJihua. MEDIUM-TERM EFFECTIVENESS OF Waveflex SYSTEM IN TREATMENT OF MULTIPLE LUMBAR DEGENERATIVE DISEASES. Chinese Journal of Reparative and Reconstructive Surgery, 2015, 29(9): 1104-1108. doi: 10.7507/1002-1892.20150239 Copy

1.	Kumar MN, Jacquot F, Hall H. Long term follow-up of functional outcomes and radiographic changes at adjacent levels following lumbar spine fusion for degenerative disc disease. Eur Spine J, 2001, 10(4):309-313.
2.	Ekman P, Möller H, Shalabi A, et al. A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration. Eur Spine J, 2009, 18(8):1175-1186.
3.	Sapkas GS, Themistocleous GS, Mavrogenis AF, et al. Stabilization of the lumbar spine using the dynamic neutralization system. Orthopedics, 2007, 30(10):859-865.
4.	Fu L, France A, Xie Y, et al. Functional and radiological outcomes of semi-rigid dynamic lumbar stabilization adjacent to single-level fusion after 2 years. Arch Orthop Trauma Surg, 2014, 134(5):605-610.
5.	Schaeren S, Broger I, Jeanneret B. Minimum four-year follow-up of spinal stenosis with degenerative spondylol isthesis treated with decompression and dynamic stabilization. Spine (Phila Pa 1976), 2008, 33(18):E636-642.
6.	Pfirrmann CW, Metzdorf A, Zanetti M, et al. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976), 2001, 26(17):1873-1878.
7.	Stauffer RN, Coventry MB. Anterior interbody lumbar spine fusion. Analysis of Mayo clinic series. J Bone Joint Surg (Am), 1972, 54(4): 756-758.
8.	张力, 舒小秋, 段杨, 等. ISOBAR TTL 半坚强后路动态内固定系统治疗腰椎退行性疾病疗效观察. 中国修复重建外科杂志, 2012, 26(9):1066-1070.
9.	Brantigan JW, Stefee AD. A carbon fiber implant to aid interbody lumbar fusion:two-year clinical results in the first 26 patients. Spine (Phila Pa 1976), 1993, 18(14):2106-2117.
10.	Choi Y, Kim K, So K. Adjacent segment instability after treatment with a Graf ligament at minimum 8 years' followup. Clin Orthop Relat Res, 2009, 467(7):1740-1746.
11.	胡明, 马远征, 李大伟, 等. WavefleX动态稳定系统治疗腰椎退变性疾病的早期临床观察. 中国骨与关节外科, 2013, 6(2):113-116.
12.	Strube P, Tohtz S, Hoff E, et al. Dynamic stabilization adjacent to single-level fusion:part I. Biomechanical effects on lumbar spinal motion. Eur Spine J, 2010, 19(12):2171-2180.
13.	Kumar A, Beastall J, Hughes J, et al. Disc changes in the bridged and adjacent segments after Dynesys dynamic stabilization system after two years. Spine (Phila Pa 1976), 2008, 33(26):2909-2914.
14.	Harrop JS, Youssef JA, Maltenfort M, et al. Lumbar adjacent segment degeneration and disease after arthrodesis and total disc arthroplasty. Spine (Phila Pa 1976), 2008, 33(15):1701-1707.
15.	Nakai S, Yoshizawa H, Kobayashi S. Long-term follow-up study of posterior lumbar interbody fusion. J Spinal Disord, 1999, 12(4):293-299.
16.	Reyes-Sánche A, Zárate-Kalfópulos B, Isabel RM, et al. 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, 2010, 19(12):2164-2170.
17.	Vaga S, Brayda-Bruno M, Perona F, et al. Molecular MR imaging for the evaluation of the effect of dynamic stabilization on lumbar intervertebral discs. Eur Spine J, 2009, 18 Suppl 1:40-48.
18.	Fay LY, Wu JC, Tsai TY, et al. Intervertebral disc rehydration after lumbar dynamic stabilization:magnetic resonance image evaluation with a mean follow-up of four years. Adv Orthop, 2013, (2013): 437570.

1. Kumar MN, Jacquot F, Hall H. Long term follow-up of functional outcomes and radiographic changes at adjacent levels following lumbar spine fusion for degenerative disc disease. Eur Spine J, 2001, 10(4):309-313.
2. Ekman P, Möller H, Shalabi A, et al. A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration. Eur Spine J, 2009, 18(8):1175-1186.
3. Sapkas GS, Themistocleous GS, Mavrogenis AF, et al. Stabilization of the lumbar spine using the dynamic neutralization system. Orthopedics, 2007, 30(10):859-865.
4. Fu L, France A, Xie Y, et al. Functional and radiological outcomes of semi-rigid dynamic lumbar stabilization adjacent to single-level fusion after 2 years. Arch Orthop Trauma Surg, 2014, 134(5):605-610.
5. Schaeren S, Broger I, Jeanneret B. Minimum four-year follow-up of spinal stenosis with degenerative spondylol isthesis treated with decompression and dynamic stabilization. Spine (Phila Pa 1976), 2008, 33(18):E636-642.
6. Pfirrmann CW, Metzdorf A, Zanetti M, et al. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976), 2001, 26(17):1873-1878.
7. Stauffer RN, Coventry MB. Anterior interbody lumbar spine fusion. Analysis of Mayo clinic series. J Bone Joint Surg (Am), 1972, 54(4): 756-758.
8. 张力, 舒小秋, 段杨, 等. ISOBAR TTL 半坚强后路动态内固定系统治疗腰椎退行性疾病疗效观察. 中国修复重建外科杂志, 2012, 26(9):1066-1070.
9. Brantigan JW, Stefee AD. A carbon fiber implant to aid interbody lumbar fusion:two-year clinical results in the first 26 patients. Spine (Phila Pa 1976), 1993, 18(14):2106-2117.
10. Choi Y, Kim K, So K. Adjacent segment instability after treatment with a Graf ligament at minimum 8 years' followup. Clin Orthop Relat Res, 2009, 467(7):1740-1746.
11. 胡明, 马远征, 李大伟, 等. WavefleX动态稳定系统治疗腰椎退变性疾病的早期临床观察. 中国骨与关节外科, 2013, 6(2):113-116.
12. Strube P, Tohtz S, Hoff E, et al. Dynamic stabilization adjacent to single-level fusion:part I. Biomechanical effects on lumbar spinal motion. Eur Spine J, 2010, 19(12):2171-2180.
13. Kumar A, Beastall J, Hughes J, et al. Disc changes in the bridged and adjacent segments after Dynesys dynamic stabilization system after two years. Spine (Phila Pa 1976), 2008, 33(26):2909-2914.
14. Harrop JS, Youssef JA, Maltenfort M, et al. Lumbar adjacent segment degeneration and disease after arthrodesis and total disc arthroplasty. Spine (Phila Pa 1976), 2008, 33(15):1701-1707.
15. Nakai S, Yoshizawa H, Kobayashi S. Long-term follow-up study of posterior lumbar interbody fusion. J Spinal Disord, 1999, 12(4):293-299.
16. Reyes-Sánche A, Zárate-Kalfópulos B, Isabel RM, et al. 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, 2010, 19(12):2164-2170.
17. Vaga S, Brayda-Bruno M, Perona F, et al. Molecular MR imaging for the evaluation of the effect of dynamic stabilization on lumbar intervertebral discs. Eur Spine J, 2009, 18 Suppl 1:40-48.
18. Fay LY, Wu JC, Tsai TY, et al. Intervertebral disc rehydration after lumbar dynamic stabilization:magnetic resonance image evaluation with a mean follow-up of four years. Adv Orthop, 2013, (2013): 437570.

Chinese Journal of Reparative and Reconstructive Surgery

MEDIUM-TERM EFFECTIVENESS OF Waveflex SYSTEM IN TREATMENT OF MULTIPLE LUMBAR DEGENERATIVE DISEASES

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