Lanman Todd H, Burkus J Kenneth, Dryer Randall G, Gornet Matthew F, McConnell Jeffrey, Hodges Scott D
Institute for Spinal Disorders, Cedars-Sinai Medical Center, Los Angeles, California.
Wilderness Spine Services, Columbus, Georgia.
J Neurosurg Spine. 2017 Jul;27(1):7-19. doi: 10.3171/2016.11.SPINE16746. Epub 2017 Apr 7.
OBJECTIVE The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF). METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations. RESULTS At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure-related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure-related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] -1.19 [-2.29 to -0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR -1.29 [95% BCI -2.12 to -0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months. CONCLUSIONS The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion. Clinical trial registration no.: NCT00637156 (clinicaltrials.gov).
目的 本研究旨在评估与颈椎前路椎间盘切除融合术（ACDF）相比，使用Prestige LP人工椎间盘置换（ADR）假体治疗相邻两个节段退行性颈椎疾病的患者的长期临床安全性和有效性。方法 在美国30个中心进行了一项前瞻性、随机、对照、多中心的FDA批准的临床试验，比较两个节段的低轮廓钛陶瓷复合材料Prestige LP ADR（n = 209）与ACDF（n = 188）。在术前、术中及术后定期随访至84个月时完成临床和影像学评估。主要终点是总体成功率，这是一个综合变量，包括关键的安全性和有效性考量。结果 在84个月时，Prestige LP ADR在总体成功率（观察率78.6%对62.7%；优势后概率[PPS]=99.8%）、颈部功能障碍指数成功率（87.0%对75.6%；PPS = 99.3%）和神经功能成功率（91.6%对82.1%；PPS = 99.0%）方面显示出优于融合术的统计学优势。与ACDF相比，ADR的所有其他研究有效性指标至少为非劣效。在长达84个月的时间里，植入相关或植入/手术操作相关不良事件的总体发生率无统计学显著差异（分别为26.6%和27.7%）。然而，Prestige LP组与植入物或植入物/手术操作相关的严重（3级或4级）不良事件较少（3.2%对7.2%，对数风险比[LHR]和95%贝叶斯可信区间[95% BCI] -1.19 [-2.29至-0.15]）。Prestige LP组患者在索引节段进行的二次手术也比融合组（14.7%）在统计学上显著更少（4.2%）（LHR -1.29 [95% BCI -2.12至-0.46]）。Prestige LP ADR组在治疗的上下节段平均角度活动范围在84个月时得以维持。结论 本研究中的低轮廓人工颈椎间盘Prestige LP，在相邻两个节段植入后，在术后84个月维持了改善的临床结果和节段活动度，是融合术的一种安全有效的替代方法。临床试验注册号：NCT00637156（clinicaltrials.gov）。
