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Mobi-C 研究性设备豁免临床试验:1 至 2 节颈椎间盘置换术的 10 年结果。

Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial.

机构信息

Department of Neurological Surgery, UC Davis Health, Sacramento, California.

Orthopaedics Northeast, Fort Wayne, Indiana.

出版信息

Neurosurgery. 2021 Feb 16;88(3):497-505. doi: 10.1093/neuros/nyaa459.


DOI:10.1093/neuros/nyaa459
PMID:33372218
Abstract

BACKGROUND: Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE: To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS: This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS: At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION: Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

摘要

背景:短期和中期研究已经表明颈椎间盘置换术(CDA)治疗颈椎间盘退变的有效性。

目的:报告多中心使用 Mobi-C®颈椎间盘(捷迈邦美)治疗 1 至 2 个节段病变的 10 年结果。

方法:这是一项前瞻性研究,使用 Mobi-C®颈椎间盘(捷迈邦美)对 1 或 2 个连续节段进行 CDA 治疗,共纳入 9 个高入组中心的患者。在完成 7 年的 FDA 批准后研究后,对同意的患者继续进行 10 年随访。收集至 10 年的临床和影像学终点。

结果:在 10 年时,患者的颈部残疾指数(NDI)、颈部和手臂疼痛、神经功能和节段活动度(ROM)继续显著改善。10 年时的 NDI 和疼痛结果显著优于 7 年时的结果。7 至 10 年时,节段和整体 ROM 和矢状面排列也得到维持。7 年和 10 年时,临床相关的相邻节段病变无显著差异。1 个节段(30.7%比 29.6%)或 2 个节段(41.7%比 39.2%)患者的运动受限异位骨化的发生率在 10 年时与 7 年时无显著差异。7 年后仅报告了 2 例后续手术。

结论:我们 10 年的结果与 7 年的结果相当,表明使用 Mobi-C 的 CDA 仍然是治疗 1 或 2 个节段颈椎退行性椎间盘疾病患者的安全有效的手术治疗方法。

相似文献

[1]
Ten-Year Outcomes of 1- and 2-Level Cervical Disc Arthroplasty From the Mobi-C Investigational Device Exemption Clinical Trial.

Neurosurgery. 2021-2-16

[2]
Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article.

J Neurosurg Spine. 2014-7-18

[3]
Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level.

J Neurosurg Spine. 2019-5-10

[4]
Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results.

J Neurosurg Spine. 2015-1

[5]
Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article.

J Neurosurg Spine. 2013-9-6

[6]
Clinical and radiographic outcomes of cervical disc arthroplasty with Prestige-LP Disc: a minimum 6-year follow-up study.

BMC Musculoskelet Disord. 2018-8-7

[7]
Is cervical disc arthroplasty good for congenital cervical stenosis?

J Neurosurg Spine. 2017-5

[8]
Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.

J Neurosurg Spine. 2016-8

[9]
Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome.

J Neurosurg Spine. 2016-11

[10]
Clinical and radiographic comparison of cervical disc arthroplasty with Prestige-LP Disc and anterior cervical fusion: A minimum 6-year follow-up study.

Clin Neurol Neurosurg. 2018-1

引用本文的文献

[1]
Clinical and biomechanical effects of bone-implant interface gap after cervical disc replacement.

Eur Spine J. 2025-4-16

[2]
Reoperation Strategy for Failure of Cervical Disc Arthroplasty at Index and Adjacent Levels.

J Clin Med. 2025-3-17

[3]
The Future of Arthroplasty in the Spine.

Int J Spine Surg. 2025-4-7

[4]
Kinematic status of Bryan and Mobi-C artificial cervical discs post cervical hybrid surgery: a retrospective study.

J Orthop Surg Res. 2024-12-19

[5]
Combined effect of artificial cervical disc replacement and facet tropism on the index-level facet joints: a finite element study.

BMC Musculoskelet Disord. 2024-10-23

[6]
Proposal for a classification system of radiographic bone changes after cervical disc replacement.

J Orthop Surg Res. 2024-4-3

[7]
Emerging Technologies within Spine Surgery.

Life (Basel). 2023-10-9

[8]
Cervical Disc Arthroplasty for the Treatment of Noncontiguous Cervical Degenerative Disc Disease: Results of Mid- to Long-Term Follow-up.

Orthop Surg. 2023-11

[9]
Is Cervical Disc Arthroplasty an Effective Treatment for Cervical Degenerative Disease With Osteopenia?

Global Spine J. 2025-3

[10]
Cervical disc arthroplasty with the Baguera C prosthesis: clinical and radiological results of a 10-year follow-up study.

Eur Spine J. 2023-10

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