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LINK SB Charité椎间假体临床结果的多中心回顾性研究。欧洲的初步经验。

A multicenter retrospective study of the clinical results of the LINK SB Charité intervertebral prosthesis. The initial European experience.

作者信息

Griffith S L, Shelokov A P, Büttner-Janz K, LeMaire J P, Zeegers W S

机构信息

Texas Back Institute Research Foundation, Plano.

出版信息

Spine (Phila Pa 1976). 1994 Aug 15;19(16):1842-9. doi: 10.1097/00007632-199408150-00009.

DOI:10.1097/00007632-199408150-00009
PMID:7973983
Abstract

OBJECTIVE

This study is a multicenter, retrospective review of the initial clinical results of an artificial disc replacement, the LINK SB Charité intervertebral prosthesis.

METHODS

Independent analysis by chart review included patient demographics, surgical data, and a comparison of presurgical to follow-up data. Data were analyzed from 93 patients (average age = 43.0 +/- 7.3) in whom a total of 139 Model III prostheses (Waldemar Link GmbH & Co, Hamburg, Germany) were implanted.

RESULTS

The predominant diagnostic indication for the disc was degenerative disc disease (52.4%). The L4-L5 and L5-S1 levels comprised 87.1% of all levels implanted. The average follow-up was 11.5 +/- 8.4 months. After disc implantation, a significant proportion of the patient sample experienced pain relief (P < 0.05). Improvements were also noted in pain intensity, walking distance, lumbar mobility, and the percentage of patients showing a positive SLR or neurological weakness. No difference in work status after disc implantation could be detected. Device failure, migration, or dislocation occurred in 6 of 93 (6.5%) patients.

CONCLUSIONS

This study represents the largest multicenter case series of any functional artificial disc implantation. Carefully controlled, prospective studies that compare disc implantation and fusion are warranted.

摘要

目的

本研究是一项多中心回顾性研究,旨在分析LINK SB Charité人工椎间盘置换术的初步临床结果。

方法

通过病历回顾进行独立分析,内容包括患者人口统计学资料、手术数据以及术前与随访数据的对比。对93例患者(平均年龄=43.0±7.3岁)的数据进行了分析,这些患者共植入了139枚III型假体(德国汉堡的Waldemar Link GmbH & Co公司生产)。

结果

椎间盘置换的主要诊断指征是椎间盘退变疾病(52.4%)。L4-L5和L5-S1节段占所有植入节段的87.1%。平均随访时间为11.5±8.4个月。椎间盘植入后,相当一部分患者的疼痛得到缓解(P<0.05)。疼痛强度、步行距离、腰椎活动度以及直腿抬高试验阳性或存在神经功能障碍的患者比例也有所改善。椎间盘植入后工作状态未发现差异。93例患者中有6例(6.5%)出现假体故障、移位或脱位。

结论

本研究是任何功能性人工椎间盘植入的最大规模多中心病例系列。有必要进行严格对照的前瞻性研究,以比较椎间盘植入术和融合术。

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