Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial
Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial
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DOI：
10.3171/2014.6.spine13996
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发表时间：
2014-10-01
影响因子：
2.8
通讯作者：
Mummaneni, Praveen V.
中科院分区：
文献类型：
--
作者：
Burkus, J. Kenneth;Traynelis, Vincent C.;Mummaneni, Praveen V.
目的。作者在一项前瞻性、随机、多中心试验中评估了使用 Prestige 颈椎间盘置换术的长期安全性和有效性，并进行了 7 年的随访。方法。在 31 个研究中心，541 名患有单节段颈椎间盘疾病伴神经根病的患者被随机分为 2 个治疗组中的 1 个：276 名研究组患者接受前路颈椎间盘切除术和 Prestige 椎间盘置换术，265 名对照组患者接受前路颈椎间盘切除术和融合术。临床结果包括颈部残疾指数、36 项简短健康调查以及颈部和手臂疼痛评分。评估射线照片的运动角度和融合角度。在术前、术中以及 1.5、3、6、12、24、36、60 和 84 个月时评估临床和影像学结果。结果。在 541 名接受治疗的患者中，395 名患者（73%；212 名研究患者和 183 名对照患者）完成了 7 年的临床随访。两组均在 1.5 个月内取得了显着改善，并持续了 7 年。在研究组中，60 个月和 84 个月时颈部残疾指数较术前评分平均改善分别为 38.2 和 37.5。在对照组中，相应的平均值为 33.8 和 31.9。研究组和对照组在 60 个月和 84 个月期间的差异显着（分别为 p = 0.014 和 0.002）。研究组神经系统状态维持或改善的总体比率显着较高：60 个月和 84 个月时分别为 92.2% 和 88.2%，而对照组为 85.7% 和 79.7%（p 分别为 0.017 和 0.011）。 84 个月时，研究组中在职患者的比例为 73.9%，对照组为 73.1%。术后，种植体在 60 个月时有效维持平均角运动 6.67 度，在 84 个月时有效维持 6.75 度。指数水平的累计手术率较低（p
Object. The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up.Methods. At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty With the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months.Results. Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67 degrees at 60 months and 6.75 degrees at 84 months. Cumulative rates for surgery at the index level were lower (p