Frank H Netter School of Medicine, Quinnipiac University, COS, Hamden, CT.
Orthopedic Care Center, Aventura, FL.
Spine (Phila Pa 1976). 2019 Dec 15;44(24):1685-1696. doi: 10.1097/BRS.0000000000003171.
A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.
The aim of this study was to compare the 5-year safety and effectiveness of the activL Artificial Disc with Control Total Disc Replacement (TDR) systems (ProDisc-L or Charité) in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD).
The activL Artificial Disc received Food and Drug Administration approval in 2015 based on 2-year follow-up data.
Eligible patients presented with symptomatic, single-level, lumbar DDD who failed ≥6 months of nonsurgical management. At entry, 324 patients were randomly allocated (2 : 1) to treatment with activL (n = 218) or Control (n = 106, including n = 65 ProDisc-L and n = 41 Charité) TDR. At 5-year follow up, a total of 261 patients (176 activL patients and 85 Control patients) were available for analysis.
The primary composite endpoint at 5 years for activL patients was noninferior to Control TDR. Relative to baseline, reductions in back pain severity and improvements in Oswestry Disability Index (ODI) were maintained for both the activL and Control TDR groups through 5 years. The activL group showed significantly better range of motion for flexion-extension rotation, flexion-extension translation, and disc angle, compared with Control TDR. Freedom from a serious adverse event through 5 years was 64% in activL patients, 47% in Control patients (log-rank P = 0.0068). Freedom from index-level and adjacent-level reoperation was high for TDR patients, ranging between 94% and 99%, respectively.
Long-term evidence supports lumbar total disc replacement as safe. The next-generation activL Artificial Disc is more effective at preserving range of motion than first-generation lumbar TDRs (ProDisc-L and Charité) and offers a higher safety profile. Other primary and secondary outcomes are similar between disc designs.
一项前瞻性、多中心、随机、对照、研究性器械豁免（IDE）非劣效性试验。
本研究旨在比较 activL 人工椎间盘与对照全椎间盘置换（TDR）系统（ProDisc-L 或 Charité）治疗有症状的单节段腰椎退行性椎间盘疾病（DDD）患者的 5 年安全性和有效性。
activL 人工椎间盘于 2015 年获得美国食品和药物管理局批准，依据是 2 年随访数据。
符合条件的患者表现为有症状的、单节段、腰椎 DDD，且经过≥6 个月的非手术治疗失败。入组时，324 名患者被随机分配（2:1）接受 activL（n=218）或对照（n=106，包括 n=65 ProDisc-L 和 n=41 Charité）TDR 治疗。5 年随访时，共有 261 名患者（176 名 activL 患者和 85 名对照患者）可进行分析。
activL 患者的主要复合终点在 5 年时不劣于对照 TDR。与基线相比，activL 和对照 TDR 两组的腰痛严重程度均降低，Oswestry 功能障碍指数（ODI）均改善，且持续至 5 年。与对照 TDR 相比，activL 组的屈伸旋转、屈伸平移和椎间盘角度的活动范围明显更好。5 年时，activL 患者的严重不良事件发生率为 64%，对照患者为 47%（对数秩 P=0.0068）。TDR 患者的索引节段和相邻节段再手术率均较高，分别为 94%和 99%。
长期证据支持腰椎全椎间盘置换术的安全性。新一代 activL 人工椎间盘在保留活动范围方面比第一代腰椎 TDR（ProDisc-L 和 Charité）更有效，并具有更高的安全性。两种椎间盘设计的主要和次要结果相似。
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