Efficacy and safety of artificial total disc replacement in the treatment of lumbar degenerative diseases

doi:10.3969/j.issn.2095-4344.0192

Abstract

Abstract:

BACKGROUND: At present, lumbar fusion, which is widely used in the treatment of lumbar degenerative diseases, usually leads to lumbar stiffness and acceleration of adjacent segment degeneration. Non fusion, such as total disc replacement, is an effective way to avoid these problems, but there are some disputes about the value and indications.

OBJECTIVE: To evaluate the efficacy and safety of total disc replacement in the treatment of lumbar degenerative diseases.

METHODS: Totally 97 cases of degenerative diseases of the lumbar spine were treated by surgical treatment, and they were divided into 2 groups according to the operation methods. 55 cases underwent lumbar fusion surgery in the fusion group and 42 cases underwent artificial total disc replacement in the replacement group. All patients were followed up for 6 years. The Visual Analogue Scale (VAS) score, Oswestry Dysfunction Index (ODI), and the incidence of complication were compared between the two groups before and after the operation.

RESULTS AND CONCLUSION: (1) There were no significant differences in general information, VAS score, and ODI between the two groups before operation (P > 0.05). (2) The operation time and postoperative hospital stay in the replacement group were significantly shorter than that in the fusion group, and the amount of bleeding during operation was significantly lower in the replacement group than that in the fusion group (P < 0.01). (3) The scores of VAS and ODI in two groups were significantly lower after operation than those before operation (P < 0.01). The VAS score and ODI in the replacement group were significantly lower than that in the fusion group at postoperative 6 months and 1 year after operation (P < 0.01). (4) The incidence of complications in the replacement group (2%) was significantly lower than that in the fusion group (5%) (P < 0.05). (5) In conclusion, artificial total disc replacement for the treatment of degenerative lumbar disease can effectively relieve the pain of lumbago and leg, improve the lumbar function and have better medium-term and long-term effects.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Intervertebral Disk Degeneration, Spinal Fusion, Internal Fixators, Tissue Engineering

CLC Number:

R318

Chen Jun, Wu Guang-hui. Efficacy and safety of artificial total disc replacement in the treatment of lumbar degenerative diseases[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(19): 2961-2967.

Figures/Tables 1

2.1 参与者数量分析按意向性处理分析，入选患者97例，均完成6年随访，所有患者随访数据均计入结果进行分析。试验流程图见图1。 2.2 两组患者一般资料分析 2组患者一般资料比较差异无显著性意义，具有可比性，见表1。 2.3 两组患者手术情况与住院时间分析置换组手术时间、术后住院时间明显短于融合组，术中出血量明显少于融合组(P < 0.01)，见表2。 2.4 两组患者目测类比评分与ODI变化 2组患者术后各随访时点目测类比评分与ODI较术前有明显改善(P < 0.01)；2组间术后6个月、1年目测类比评分与ODI差异有显著性意义(P < 0.01)；2组间术前、术后6年目测类比评分与ODI差异无显著性意义(P > 0.05)；融合组内各随访点间目测类比评分与ODI差异有显著性意义(P < 0.01)；置换组术后1年与术后6个月、6年目测类比评分差异有显著性意义(P < 0.01)；置换组内各随访点间ODI差异有显著性意义(P < 0.01)，见表3。 2.5 典型病例病例1：融合组男性患者，46岁，下腰痛3年，诊断为腰椎间盘退行性变、腰椎间盘突出症、椎间盘源性腰痛。采取腰椎后路单椎间融合器融合与双侧钉棒内固定系统内固定治疗，术后随访6年，X射线片可见融合器与钉棒位置良好，骨桥形成，融合效果良好(图2)。病例2：置换组男性患者，45岁，下腰痛4年，诊断为腰椎间盘突出症与椎间盘源性腰痛。采取Link SB CharitéⅢ型人工椎间盘假体置换病变椎间盘并进行生物固定治疗，术后随访6年，X射线片可见椎间盘假体位置良好，椎间盘置换节段具有良好ROM，置换效果满意(图3)。 2.6 并发症分析融合组55例患者术后随访6年，融合内固定手术过程中有1例患者因牵拉引起神经根损伤导致下肢疼痛，对症治疗10 d后疼痛消失；术后手术切口无感染、钉棒内固定系统无松动或断裂、椎间融合器无移位或脱出；末次随访发现2例患者出现关节突关节轻度增生；并发症发生率为5%。置换组42例患者术后随访6年，人工腰椎间盘置换过程中未出现神经、血管损伤和腹膜撕裂；术后出现1例患者发生摔伤后椎体骨折行再次手术治疗不计入手术原因引起的并发症，1例患者出现小关节轻度退变；术后未出现切口感染、人工椎间盘假体位置不良、异位骨化引起的椎间隙融合、植入物机械故障、小关节退变、切口疝和犁状肌综合征等并发症；末次随访手术节段活动度良好；并发症发生率为2%。 "

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