Two-level total disc replacement with Mobi-C(r) over 3-years

Objective: To evaluate the safety and effectiveness of two-level total disc replacement (TDR) using a Mobi-C(r) Cervical Artificial Disc at the 36 month follow-up. Methods: a Prospective, randomized, controlled, multicenter clinical trial of an artificial cervical disc (Mobi-C(r) Cervical Artificial Disc) was conducted under the Investigational Device Exemptions (IDE) and the U.S. Food & Drug Administration (FDA) regulations. A total of 339 patients with degenerative disc disease were enrolled to receive either two-level treatment with TDR, or a two-level anterior cervical discectomy and fusion (ACDF) as control. The 234 TDR patients and 105 ACDF patients were followed up at regular time points for three years after surgery. Results: At 36 months, both groups demonstrated an improvement in clinical outcome measures and a comparable safety profile. NDI scores, SF-12 PCS scores, patient satisfaction, and overall success indicated greater statistically significant improvement from baseline for the TDR group, in comparison to the ACDF group. The TDR patients experienced lower subsequent surgery rates and a lower rate of adjacent segment degeneration. On average, the TDR patients maintained segmental range of motion through 36 months with no device failure. Conclusion: Results at three-years support TDR as a safe, effective and statistically superior alternative to ACDF for the treatment of degenerative disc disease at two contiguous cervical levels.研究目的：在36个月随访周期内，评估采用Mobi-C(r)颈椎人工椎间盘（Mobi-C(r) Cervical Artificial Disc）的双节段全椎间盘置换术（total disc replacement, TDR）的安全性与有效性。 研究方法：本研究为一项依据研究器械豁免（Investigational Device Exemptions, IDE）及美国食品药品监督管理局（U.S. Food & Drug Administration, FDA）相关法规开展的前瞻性、随机对照多中心临床试验，受试器械为Mobi-C(r)颈椎人工椎间盘。共计纳入339例退行性椎间盘疾病患者，随机分为两组，分别接受双节段全椎间盘置换术治疗，或作为对照的双节段颈椎前路椎间盘切除融合术（anterior cervical discectomy and fusion, ACDF）。其中234例接受TDR治疗的患者与105例接受ACDF治疗的患者，在术后三年内按常规随访节点接受随访评估。 研究结果：术后36个月时，两组患者的临床结局指标均得到改善，且安全性表现相当。与ACDF组相比，TDR组的颈椎功能障碍指数（Neck Disability Index, NDI）评分、SF-12生理健康综合评分（SF-12 Physical Component Summary, PCS）、患者满意度及整体成功率较基线水平的改善幅度具有更显著的统计学意义。TDR组患者的后续手术率及相邻节段退变发生率均更低。平均而言，TDR组患者在36个月随访期内维持了手术节段的活动度，未出现器械失效情况。 研究结论：三年随访结果证实，针对相邻两节段颈椎退行性椎间盘疾病的治疗，TDR是一种安全、有效且统计学上优于ACDF的替代治疗方案。