Phillips Frank M, Geisler Fred H, Gilder Kye M, Reah Christopher, Howell Kelli M, McAfee Paul C
*Midwest Orthopaedics at Rush University Medical Center, Chicago, IL †Chicago Back Institute, Chicago, IL ‡Kye Gilder Consulting, LLC, San Diego, CA §NuVasive, Inc., San Diego, CA; and ¶University of Maryland St. Joseph Medical Center, Baltimore, MD.
Spine (Phila Pa 1976). 2015 May 15;40(10):674-83. doi: 10.1097/BRS.0000000000000869.
Prospective, multicenter, randomized clinical trial.
To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.
The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.
Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.
At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.
The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
前瞻性、多中心、随机临床试验。
评估PCM颈椎间盘与颈椎前路椎间盘切除融合术（ACDF）相比，在治疗C3 - C4至C7 - T1节段有症状的单节段退变性颈椎病患者（无论是否有先前颈椎融合术史）中的长期安全性和有效性。
PCM颈椎间盘试验的2年结果先前已报道。本研究报告同一试验的长期结果。
纳入对非手术治疗无反应的单节段颈椎病伴神经根病（无论是否有脊髓病）患者。5年时符合方案的患者样本包括293例患者（163例PCM，130例ACDF）。通过当前随访报告队列中的不良事件和二次手术情况，其中7年时包括110例患者（68例PCM，42例ACDF）。
术后5年，两组患者报告的所有结局指标——颈部和手臂疼痛视觉模拟量表评分、颈部功能障碍指数和总体健康状况（36项简短健康调查问卷身体和精神成分评分：身体成分总结、精神成分总结）均较基线有显著改善，且PCM组在颈部功能障碍指数（P = 0.001）、颈部疼痛（P = 0.002）、总体健康状况（身体成分总结P = 0.014；精神成分总结P = 0.004）和患者满意度（P = 0.005）方面的平均得分显著更好。PCM患者在2至7年与器械相关的严重不良事件（1/214，0.5% PCM；2/190，1.1% ACDF）和二次手术（7/211，3.3% PCM；14/290，7.6% ACDF）方面有减少趋势。影像学上，ACDF术后相邻节段退变更常见（33.1% PCM，50.9% ACDF；P = 0.006），且是ACDF术后晚期二次手术增加的主要原因。
长期结果显示ACDF和PCM人工关节置换术后临床效果良好。PCM患者在颈部功能障碍指数和颈部疼痛评分方面改善更大，影像学相邻节段退变率更低，二次手术趋势更少。这些数据支持PCM人工关节置换术是ACDF一种可行且可持续的替代方案。
1级
