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采用Mobi-C人工颈椎间盘置换术治疗颈椎间盘退变疾病的疗效与安全性的多中心观察性研究。10年随访结果

Observational, Multicenter Study of the Efficacy and Safety of Cervical Disk Arthroplasty With Mobi-C in the Treatment of Cervical Degenerative Disk Disease. Results at 10 years Follow-Up.

作者信息

Steib Jean-Paul, Dufour Thierry, Beaurain Jacques, Bernard Pierre, Huppert Jean

机构信息

Spine Department, University Hospital, Strasbourg, France.

Parisian Institute, Geoffroy Saint-Hilaire Clinic, Paris, France.

出版信息

Spine (Phila Pa 1976). 2023 Apr 1;48(7):452-459. doi: 10.1097/BRS.0000000000004536. Epub 2022 Nov 14.

DOI:10.1097/BRS.0000000000004536
PMID:36730682
Abstract

BACKGROUND

Cervical disk arthroplasty replacement (CDA) was developed to avoid specific disadvantages of cervical fusion. The purpose of this paper is to provide 10-year follow-up results of an ongoing prospective study after CDA.

METHODS

Three hundred eighty-four patients treated using the Mobi-C (ZimVie, Troyes, France) were included in a prospective multicenter study. Routine clinical and radiologic examinations were reported preoperatively and postoperatively with up to 10-year follow-up. Complications and revision surgeries were also documented.

RESULTS

At 10 years showed significant improvement in all clinical outcomes [Neck Disability Index, visual analog scale (VAS) for arm and neck pain, physical component summary of SF36, and mental component summary of SF36). Motion at the index level increased significantly over baseline (mean range of motion=7.6 vs. 8 degrees at five years and 6.0 degrees preoperatively; P <0.001) and 71.3% of the implanted segments remained mobile (range of motion>3 degrees). Adjacent disks were also mobile at 10 years with the same mobility as preoperatively. At 10 years, 20.9% of the implanted segments demonstrated no heterotopic ossification. Thirty-four patients (8.9%) experienced 41 adverse events, with or without reoperation during the first five years. We found only two additional surgeries after five years. We observed an increased percentage of working patients and a decrease in medication consumption. Regarding the overall outcome, 94% of patients were satisfied.

CONCLUSIONS

Our 10-year results showed significant improvement in all clinical outcomes, with low rates of revision or failure. This experience in patients with long-term follow-up after CDA endorses durable, favorable outcomes in properly selected patients.

摘要

背景

颈椎间盘置换术(CDA)的研发是为了避免颈椎融合术的特定缺点。本文旨在提供CDA前瞻性研究的10年随访结果。

方法

一项前瞻性多中心研究纳入了384例使用Mobi-C(法国特鲁瓦的ZimVie公司)进行治疗的患者。术前和术后均进行常规临床和影像学检查,随访时间长达10年。并发症和翻修手术也有记录。

结果

10年时所有临床结局均有显著改善[颈部功能障碍指数、手臂和颈部疼痛的视觉模拟量表(VAS)、SF36身体成分总结和SF36精神成分总结]。手术节段的活动度较基线水平显著增加(五年时平均活动度范围为7.6°,术前为8°,术前为6.0°;P<0.001),71.3%的植入节段仍可活动(活动度>3°)。10年时相邻椎间盘也可活动,活动度与术前相同。10年时,20.9%的植入节段未出现异位骨化。34例患者(8.9%)在最初五年内经历了41次不良事件,有或没有再次手术。五年后我们仅发现另外两例手术。我们观察到工作患者的比例增加,药物消耗量减少。关于总体结局,94%的患者表示满意。

结论

我们的10年结果显示所有临床结局均有显著改善,翻修或失败率较低。CDA术后长期随访患者的这一经验支持了在适当选择的患者中可获得持久、良好的结局。

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