Department of Neurological Surgery, UC Davis Health, Sacramento, California.
Orthopaedics Northeast, Fort Wayne, Indiana.
Neurosurgery. 2021 Feb 16;88(3):497-505. doi: 10.1093/neuros/nyaa459.
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.
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。
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