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颈椎间盘置换术的临床和影像学评估:5 年随访的前瞻性研究:384 例患者。

Clinical and radiological evaluation of cervical disc arthroplasty with 5-year follow-up: a prospective study of 384 patients.

机构信息

Institut Parisien du Dos, Clinique Geoffroy Saint Hilaire, 6 Rue Lacépède, 75005, Paris, France.

Neuro-Surgery Department, University Hospital, Dijon, France.

出版信息

Eur Spine J. 2019 Oct;28(10):2371-2379. doi: 10.1007/s00586-019-06069-z. Epub 2019 Jul 30.

DOI:10.1007/s00586-019-06069-z
PMID:31363916
Abstract

BACKGROUND

Cervical total disc replacement was developed to avoid known complications of cervical fusion. The purpose of this paper was to provide 5-year follow-up results of an ongoing prospective study after implantation of cervical disc prosthesis.

METHODS

Three hundred and eighty-four patients were treated using Mobi-C cervical disc (Zimmer Biomet, Troyes, France) and included in a prospective multicentre study. Routine clinical and radiological examinations were reported preoperatively and postoperatively with up to 5-year follow-up. Complications and revision surgeries were also explored.

RESULTS

Results at 5 years showed significant improvement in all clinical outcomes (NDI, VAS for arm and neck pain, SF-36 PCS and MCS). Motion at index level increased significantly from 6.0° preoperatively to 8.0°, and 72.1% of the implanted segments were still mobile (referring to threshold of ROM > 3°). Proximal and distal adjacent discs showed no significant change in average motion 5 years after surgery compared to baseline. Ossification resulting in complete fusion was observed in 16.4% of the implanted segments. Distal and proximal adjacent disc degeneration occurred in 42.2% and 39.1% of patients, respectively. Complications rate was 8.9%, and 1.5% of the patients had reoperation at the index level. Surgery rate of adjacent discs was 2.9%. An increased percentage of working patients and a decrease in medication consumption were observed. At 5 years, 93.3% patients were satisfied regarding the overall outcome.

CONCLUSIONS

In this study, favourable 5-year follow-up clinical and radiological outcomes were observed with a low rate of adjacent level surgery. These slides can be retrieved under Electronic Supplementary Material.

摘要

背景

颈椎间盘置换术的发展是为了避免颈椎融合术已知的并发症。本文旨在提供颈椎间盘假体植入后正在进行的前瞻性研究的 5 年随访结果。

方法

384 例患者使用 Mobi-C 颈椎间盘(捷迈邦美,法国特鲁瓦)进行治疗,并纳入前瞻性多中心研究。常规临床和影像学检查在术前和术后进行,随访时间最长达 5 年。还探讨了并发症和翻修手术。

结果

5 年结果显示所有临床结局(NDI、手臂和颈部疼痛的 VAS、SF-36 PCS 和 MCS)均显著改善。指数水平的活动度从术前的 6.0°显著增加到 8.0°,72.1%的植入节段仍具有活动度(参照 ROM>3°的阈值)。与基线相比,术后 5 年近端和远端相邻椎间盘的平均活动度没有明显变化。在 16.4%的植入节段观察到导致完全融合的骨化。42.2%和 39.1%的患者分别出现远端和近端相邻椎间盘退变。并发症发生率为 8.9%,1.5%的患者在指数水平进行了再次手术。相邻椎间盘手术率为 2.9%。观察到更多的患者恢复工作,药物使用减少。5 年后,93.3%的患者对整体结果满意。

结论

在这项研究中,观察到了良好的 5 年随访临床和影像学结果,且相邻节段手术率较低。这些幻灯片可在电子补充材料中检索。

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