Waveflex elastic fixation and discectomy annulus in repair and reconstruction of spinal stability in patients with lumbar disc herniation

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1 Chinese Journal of Tissue Engineering Research October 22, 2015 Vol.19, No.44 Waveflex ( ) 1 Waveflex 2 3 Waveflex Waveflex (XZB201311) Waveflex Waveflex Waveflex 20 (JOA)Oswestry (ODI) X 1220 JOA ODI (P < 0.05) JOA ODI (P < 0.05) (P < 0.05)Waveflex :R318 :A : (2015) Waveflex [J] (44): doi: /j.issn Waveflex elastic fixation and discectomy annulus in repair and reconstruction of spinal stability in patients with lumbar disc herniation Zhang Zhao-chuan, Jiang Xiao-wei, Dai Wei-xiang, Wu De-hui, Ma Chao, Wang Zhao-hong, Han Meng, Feng Jie, Liu Guang-pu (Department of Orthopedics, Xuzhou Central Hospital, Xuzhou , Jiangsu Province, China) Abstract BACKGROUND: For reason of pathological particularity, treatments for young adult patients with lumbar disc herniation require more demanding procedures. Traditional discectomy and rigid fixation and fusion receive a lower clinical satisfaction rate because of their concomitant complications. Waveflex is a semi-rigid fixation system with non-fusion pedicle screws. Once combined with the technology of annulus repair, it can maintain the normal movement of the segments, and can thus raise clinical satisfaction rate. OBJECTIVE: To evaluate the short-term efficacy of the treatment of young adult lumbar disc herniation through the technology of the posterior Waveflex non-fusion pedicle screw elastic fixed small window nucleus pulposus extirpation associated with annulus repair. METHODS: Thirty-eight patients with lumbar disc herniation were involved in this study, among which, 18 cases in the elastic fixation group were subjected to a posterior lumbar small window nucleus pulposus extraction along with annulus repair together bound with Waveflex elastic fixation; the rest 20 cases in the nucleus pulposus removal group underwent simple nucleus pulposus extirpation. After these operations, a series of follow-up study Zhang Zhao-chuan, Studying for doctorate, Attending physician, Department of Orthopedics, Xuzhou Central Hospital, Xuzhou , Jiangsu Province, China Corresponding author: Jiang Xiao-wei, M.D., Attending physician, Department of Orthopedics, Xuzhou Central Hospital, Xuzhou , Jiangsu Province, China Accepted: ISSN CN /R CODEN: ZLKHAH 7131

2 . Waveflex was conducted, including: follow-up analysis of clinical efficacy and complications, collection of low-back pain visual analogue scores, collection of Japanese Orthopaedic Association scores (JOA), regular assessment of Oswestry dysfunction index, and reevaluation of the lumbar lateral radiographs related indicators. RESULTS AND CONCLUSION: Follow-up visits to the patients were conducted 1220 months later since the operations. Both groups showed a better performance than before treatment in the pain visual analogue scale, low back pain JOA score, and Oswestry dysfunction index of low-back pain (P < 0.05) during the last visit. The pain visual analogue scale, low back pain JOA score, and Oswestry dysfunction index of low-back pain in the dynamic fixation group were superior to those in the nucleus pulposus removal group (P <0.05). Still in the last follow-up, operative segment disc height in the dynamic fixation group was greater than that before treatment, and the operative segment range of motion was smaller than that before treatment (P <0.05). These results suggest that compared to nucleus pulposus removal, Waveflex system associated with nucleus pulposus excision annulus repair has a more satisfactory effect in the early recovery of lumbar spine function and exerts a positive effect on the stability of the operated segments in the treatment of lumbar protrusion of the intervertebral disc in young adults. Subject headings: Lumbar Vertebrae; Intervertebral Disk Displacement; Internal Fixators; Follow-up; Tissue Engineering Funding: a Science and Technology Project Funded by Xuzhou Central Hospital Medical Doctor s Innovation Team, No.XZB Zhang ZC, Jiang XW, Dai WX, Wu DH, Ma C, Wang ZH, Han M, Feng J, Liu GP. Waveflex elastic fixation and discectomy annulus in repair and reconstruction of spinal stability in patients with lumbar disc herniation. Zhongguo Zuzhi Gongcheng Yanjiu. 2015;19(44): Introduction [1] 2030MixterBarr [2] [3] [4] Waveflex Waveflex 1Subjects and methods Waveflex Medyssey Waveflex 20 L 4/5 (P > 0.05) L 4/5 P.O. Box 10002, Shenyang

3 . Waveflex Magerl4 C ()2 mm 24 mm U 1 CX 1 24 h 24 h 2448 h24 h 3 d [5] (Japanese Orthopaedic Association ScoresJOA)Oswestry (ODI) [6] 1612 X 10 cm 010 ODI 10( )() () /50() 100% /45() 100% JOA4 9AB/C () h SPSS 19.0 (SPSS) x±st t 2 P < Results JOA ODI JOAODI (P < 0.05)12(P < 0.05)16123 (P > 0.05) JOAODI (P < 0.05)2 2.4 ISSN CN /R CODEN: ZLKHAH 7133

4 . Waveflex A B C D F G H I E 1 28 Waveflex Figure 1 Radiographs of lumbar disc protrusion patients (Male, 28 years old) before and after Waveflex elastic fixation associated with small window nucleus pulposus excision annulus repair AB X CD MRIE CT L L +waveflex FG X HI 15 X 1 Table 1 Comparison of basic information of patients in these two groups P (x±s) 28.2± ±6.1 > 0.05 (/n) 14/4 12/8 > 0.05 (x±skg) 69.9± ±4.6 > 0.05 (x±s) 9.9± ±2.8 > 0.05 (P > 0.05) 3 (x±s) Table 3 Comparison of disc height, the range of motion in lesions segments before surgery and at final follow-up in these two groups (P > 0.05) (P < 0.05) L 4/5 +Waveflex 1 3Discussion (n=18) (n=20) (mm) 7.7± ± > ± ± < 0.05 ( ) 7.4± ± > ± ± < 0.05 (P < 0.05) 4.26%0.12 [7] t P JOA ODI (x±s) Table 2 Comparison of visual analogue scores, Japanese Orthopaedic Association scores and Oswestry dysfunction index before surgery, 1 month, 6 months, 12 months after surgery and at final follow-up in these two groups (n=18) (n=20) 5.8± ± > ± ± > ± ± > ± ± < ± ± < 0.05 JOA 9.9± ± > ± ± > ± ± > ± ± > ± ± < 0.05 ODI 25.4± ± > ± ± > ± ± > ± ± > ± ± < 0.05 P < (P > 0.05)JOA ODI (P < 0.05) [8] 49.0%89.6% [9] [10] CTMRI [11] t P 7134 P.O. Box 10002, Shenyang

5 . Waveflex Maigen [12] 90% 36 [13-15] 5%10% [16-17] [18] [19-20] Waveflex Medyssey Waveflex Waveflex JOAODI [21] [22] [23-25] 5%10% Barth [26] 9 10%Jerosch [27] % ISSN CN /R CODEN: ZLKHAH 7135

6 . Waveflex Waveflex () 4 References [1],,.[M].4.:,2012. [2] Mixter WJ, Barr JS. Ruputure of the intervertebral disc with involvement of the spinal canal. New Eng Med [3]. [M].,2009: n [4] Sengupta DK. Dynamic stabilization devices in the treatmentof low back pain. Neurol India. 2005; 53(4): [5] Carlsson AM. Assessment of chronic pain. Aspects of the reliability and validity ofthe visual analogue scale. Pain. 1983; 16: [6] Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;(25): [7] Niu G. MR Imaging Assessment of Lumbar Intervertebral Disk Degeneration andage-related Changes:Apparent Diffusion Coefficient versus T2 Quantitation AJNR Am J Neuroradio Oct;32(9): [8],,.550 [J]., 2005, 5(5): [9],,.27[J].,2011,11(25):48. [10],.[J].,1996,8(6):7-8. [11],,,.[J].,2011,3(10): ,1070. [12] Maigen JY, Pime B, Deligen B.Computed tomographic follow-up studyof forty-eight cases of non-operatively treated lumbar intervertebral discherniaton. Spine. 1992;17: [13]. [J].,2014,26(10):3-6. [14].[J].,2012, 24(6): 3-8. [15],. 219[J].,2011,23(6); [16] Suk KS, Lee HM, Moon SH, et al.recurrent lumbar disc herniation: results of operative management.spine (Phila Pa 1976). 2001;26(6): [17] Erbayraktar S, Acar F, Tekinsoy B,et al. Outcome analysis of reoperations after lumbar discectomies: a report of 22 patients. Kobe J Med Sci. 2002;48(1-2): [18] Yong Hang K,Willis WH. The three-joint complex.ln: Weinstein JN, Wiesel SW, eds.the lumbar spine.1 ed.philadephia: WB sounders company, 1990: [19],,,. [J].,2006,16(9): [20] Sénégas J,Vital JM,Pointillart V, et al. Long-term actuarial survivorship analysis ofan interspinous stabilization system. Eur Spine J. 2007;16: [21] Xu HZ,Wang XY, Chi YL, et al. Biomechanical evaluation of a dynamic Pedicle screw fixation device. ClinBiomech(Bristol) Avon. 2006;21(4): [22] Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs nonoperativetreatment forlumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT)observational cohort. JAMA. 2006;296(20): [23] Ambrossi GL, McGirt MJ, Sciubba DM, et al. Recurrentlumbar disc herniation after single-level lumbar discectomy:incidence and health care cost analysis. Neurosurgery. 2009;65: [24] Carragee EJ, Spinnickie AO, Alamin TF, et al. A prospectivecontrolled study of limited versus subtotal posteriordiscectomy: short-term outcomes in patients with herniatedlumbar intervertebral discs and large posterior anular defect.spine. 2006;31: [25] Barth M, Diepers M, Weiss C. Two-year outcome afterlumbar microdiscectomy versus microscopic sequestrectomy.part 2: radiographic evaluation and correlation with clinicaloutcome. Spine. 2008;33: [26] Barth M, Weiss C, Thomé C. Two-year outcome after lumbarmicrodiscectomyversus microscopic sequestrectomy: part 1: evaluation of clinical outcome. Spine. 2008;33: [27] Jerosch J, Castro WH. Long-term results in revision surgery following lumbar disknucleotomy. Z OrthopIhreGrenzgeb. 1996;134(1): P.O. Box 10002, Shenyang

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