Coric Domagoj, Guyer Richard D, Bae Hyun, Nunley Pierce D, Strenge K Brandon, Peloza John H, Boltes Margaret O, Ohnmeiss Donna D
1Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina.
2Atrium Musculoskeletal Institute, Charlotte, North Carolina.
J Neurosurg Spine. 2022 Apr 1;37(3):357-367. doi: 10.3171/2022.1.SPINE211264. Print 2022 Sep 1.
The purpose of this study was to evaluate the safety and efficacy of a PEEK-on-ceramic cervical total disc replacement (cTDR) device for the treatment of 2-level cervical disc disease with radiculopathy and/or myelopathy.
The study was a prospective, nonrandomized, historically controlled FDA investigational device exemption trial evaluating the Simplify Cervical Artificial Disc for use at 2 levels. The anterior cervical discectomy and fusion (ACDF) control group was derived from a propensity score-matched (using subclassification) cohort of patients who participated in an earlier prospective trial in which similar indications were used. The follow-up duration was 24 months. The primary outcome was a 4-point composite success classification. Other validated clinical and radiographic assessments were also evaluated.
The investigational group (n = 182) was compared with patients who underwent ACDF (n = 170) in a historical control group using propensity score analysis. The overall composite success rate was statistically significantly greater in the cTDR group compared with the ACDF group (86.7% vs 77.1%; p < 0.05). The mean Neck Disability Index scores improved significantly in both groups, with cTDR significantly lower at some follow-up points. At the 24-month follow-up, a minimum 15-point improvement in Neck Disability Index scores was achieved in 92.9% of the cTDR group and 83.5% of the ACDF group (p > 0.05). In both groups, neck and arm pain scores improved significantly (p < 0.05) by 6 weeks and improvement was maintained throughout follow-up. Segmental range of motion was maintained at both treated segments in the cTDR group. MRI performed in the cTDR group at 24 months postoperatively found minimal changes in facet joint degeneration. The rate of subsequent surgical intervention was 2.2% in the cTDR group and 8.8% in the ACDF group.
This study adds to the growing body of literature supporting cTDR for 2-level cervical disc disease with radiculopathy or myelopathy. cTDR showed a superior overall success rate compared to ACDF, while maintaining motion. These results support that the Simplify disc is a viable alternative to ACDF in appropriately selected patients with 2-level cervical spondylosis.
本研究旨在评估一种聚醚醚酮（PEEK）陶瓷颈椎全椎间盘置换（cTDR）装置治疗伴有神经根病和/或脊髓病的两节段颈椎间盘疾病的安全性和有效性。
本研究是一项前瞻性、非随机、历史对照的美国食品药品监督管理局（FDA）研究器械豁免试验，评估用于两节段的Simplify颈椎人工椎间盘。前路颈椎间盘切除融合术（ACDF）对照组来自于倾向评分匹配（使用亚分类）的患者队列，这些患者参与了一项早期前瞻性试验，采用了相似的适应症。随访期为24个月。主要结局是一个4分的综合成功分类。还评估了其他经过验证的临床和影像学评估。
使用倾向评分分析将研究组（n = 182）与历史对照组中接受ACDF的患者（n = 170）进行比较。与ACDF组相比，cTDR组的总体综合成功率在统计学上显著更高（86.7%对77.1%；p < 0.05）。两组的颈部功能障碍指数平均得分均有显著改善，在一些随访点cTDR组显著更低。在24个月随访时，cTDR组92.9%的患者和ACDF组83.5%的患者颈部功能障碍指数得分至少提高了15分（p > 0.05）。两组的颈部和手臂疼痛评分在6周时均显著改善（p < 0.05），且在整个随访期间保持改善。cTDR组治疗的两个节段均维持了节段活动度。cTDR组术后24个月进行的磁共振成像（MRI）显示小关节退变变化极小。cTDR组后续手术干预率为2.2%，ACDF组为8.8%。
本研究为支持cTDR治疗伴有神经根病或脊髓病的两节段颈椎间盘疾病的文献增添了内容。与ACDF相比，cTDR显示出更高的总体成功率，同时保持了活动度。这些结果支持在适当选择的两节段颈椎病患者中，Simplify椎间盘是ACDF的可行替代方案。
