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活动型患者 LP-ESP 弹性体腰椎间盘置换术后的 5 年临床和影像学结果随访。

Five-year follow-up of clinical and radiological outcomes of LP-ESP elastomeric lumbar total disc replacement in active patients.

机构信息

Department of Orthopaedic Surgery, Hopital Pitié- Salpétrière, Assistance Publique-Hôpitaux de Paris, UPMC Medecine Sorbonne Universite, 91 bd de l'hopital 75013 Paris, France.

Orthopaedic Surgery, Clinique du pré, 13 av Rene Laennec 72000 Le Mans, France.

出版信息

Spine J. 2019 Feb;19(2):218-224. doi: 10.1016/j.spinee.2018.05.023. Epub 2018 May 22.

DOI:10.1016/j.spinee.2018.05.023
PMID:29800708
Abstract

BACKGROUND CONTEXT

The surgical treatment of degenerative disc disease at the lumbar spine may involve fusion. Total disc replacement (TDR) is an alternative treatment to avoid fusion-related adverse events, specifically adjacent segment disease. New generation of elastomeric non-articulating devices has been developed to more effectively replicate the shock absorption and flexural stiffness of native disc.

PURPOSE

To report 5 years clinical and radiographic outcomes, range of motion (ROM), and position of the center of rotation after a viscoelastic lumbar TDR.

STUDY DESIGN

Prospective observational cohort study PATIENT SAMPLE: Sixty-one patients OUTCOME MEASURES: The clinical evaluation was based on visual analog scale (VAS) for pain, Oswestry disability index (ODI) score, short form-36 (SF-36) including the physical component summary (PCS) and the mental component summary (MCS), and general health questionnaire-28 (GHQ28). The radiological outcomes were ROM and position of the center of rotation at the index and the adjacent levels and the adjacent disc height changes.

METHODS

Our study group included 61 consecutive patients with monosegmental disc replacement. We selected patients who could provide a global lumbar spine mobility analysis (intermediate functional activity according to the Baecke score). Hybrid constructs had been excluded. Only the cases with complete clinical and radiological follow-up at 3, 6, 12, 24, and 60 months were included.

RESULTS

There was a significant improvement in VAS (3.3±2.5 vs. 6.6±1.7, p<.001), in ODI (20±17.9 vs. 51.2±14.6, p<.001), GHQ28 (52.6±15.5 vs. 64.2±15.6, p<.001), SF-36 PCS (58.8±4.8 vs. 32.4±3.4, p<.001), and SF-36 MCS (60.7±6 vs. 42.3±3.4, p<.001). The mean location centers of the index level and adjacent discs were comparable to those previously published in asymptomatic patients. According to the definition of Zigler and Delamarter, all of our cases remained grade 0 for adjacent level disc height (within 25% of normal).

CONCLUSIONS

This series reports significant improvement in midterm follow-up after TDR, which is consistent with previously published studies but with a lower rate of revision surgery and no adjacent level disease pathologies. The radiographic assessment of the patients demonstrated the quality of functional reconstruction of the lumbar spine after LP-ESP viscoelastic disc replacement.

摘要

背景

腰椎退行性疾病的手术治疗可能涉及融合。全椎间盘置换术(TDR)是一种避免融合相关不良事件的替代治疗方法,特别是邻近节段疾病。已经开发出新一代的弹性非铰接装置,以更有效地复制天然椎间盘的减震和弯曲刚度。

目的

报告弹性腰椎 TDR 后 5 年的临床和影像学结果、运动范围(ROM)和旋转中心位置。

研究设计

前瞻性观察队列研究

患者样本

61 例患者

研究措施

临床评估基于疼痛视觉模拟量表(VAS)、Oswestry 残疾指数(ODI)评分、包括身体成分综合评分(PCS)和精神成分综合评分(MCS)的简明 36 项健康调查(SF-36)和一般健康问卷-28(GHQ28)。影像学结果为索引和相邻节段旋转中心的 ROM 和位置,以及相邻椎间盘高度变化。

方法

我们的研究组包括 61 例单节段椎间盘置换患者。我们选择了可以提供整体腰椎活动度分析(根据 Baecke 评分的中间功能活动)的患者。排除了混合结构。仅纳入在 3、6、12、24 和 60 个月时具有完整临床和影像学随访的病例。

结果

VAS(3.3±2.5 对 6.6±1.7,p<.001)、ODI(20±17.9 对 51.2±14.6,p<.001)、GHQ28(52.6±15.5 对 64.2±15.6,p<.001)、SF-36 PCS(58.8±4.8 对 32.4±3.4,p<.001)和 SF-36 MCS(60.7±6 对 42.3±3.4,p<.001)均有显著改善。索引水平和相邻椎间盘的平均中心位置与先前在无症状患者中发表的位置相当。根据 Zigler 和 Delamarter 的定义,我们所有的病例在相邻节段椎间盘高度方面均保持 0 级(在正常范围的 25%以内)。

结论

本系列报告了 TDR 后中期随访的显著改善,这与先前发表的研究一致,但翻修手术率较低,且无相邻节段疾病病理。对患者的影像学评估显示了 LP-ESP 弹性椎间盘置换后腰椎功能重建的质量。

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