Salari Nima, Konz Gina, Ferry Chris, Gandhi Anup, Freeman Andy, Davis Richard, Yeung Chris
Orthopaedic Spine Surgeon, Desert Institute for Spine Care, Phoenix, AZ, USA
Lake Region Medical, Brooklyn Park, MN, USA.
Int J Spine Surg. 2022 Apr;16(2):247-255. doi: 10.14444/8224.
No-profile anterior cervical discectomy and fusion (ACDF) devices are commonplace in spinal surgery. Contained within the intervertebral margins, these devices diminish risks associated with anterior cervical plating, while also marginalizing cage migration and subsidence. However, these devices have been limited in their scope of implant material. Accordingly, a no-profile ACDF (npACDF) device supporting a machined allograft implant body with a connected load-sharing fixation interface was developed. However, it is not established in the literature whether the device supports early mechanical stability and subsequent boney fusion. The objective of this study was to assess this device in both the clinical and preclinical settings.
Twenty-four functional spinal units (FSUs) were divided into 4 groups ( = 6). Each group would receive a single construct: (1) npACDF device with connected polyetheretherketone (PEEK) body, (2) npACDF with connected allograft body, (3) npACDF (allograft body) with nonconnected fixation plate, and (4) standard ACDF plate and PEEK interbody cage. FSUs were subjected to pure moment loading (flexion/extension, lateral bending, and axial rotation) via a kinematic test machine in their intact state and then following instrumentation. Vertebral motion was recorded and range-of-motion (ROM) reduction, relative to intact, was calculated. Ten patients receiving single-level ACDF with the npACDF allograft (connected) device for the treatment of persistent cervical radiculopathy or myelopathy were retrospectively reviewed at 12 months. Radiographic and patient reported outcomes were reported.
No differences in ROM existed between the npACDF constructs ( ≥ 0.99). Standard ACDF achieved more ROM reduction than the npACDF constructs in all directions ( ≥ 0.04). All subjects achieved fusion at 12 months.
The npACDF allograft device supported less motion reduction in comparison to traditional plating; however, case series data suggest the device provides clinically effective stability resulting in quality radiographic fusion and pain improvement.
This report provides both clinical and preclinical insight into a device which offers alternative design features to traditional continuous/rigid ACDF device designs.
无轮廓颈椎间盘切除融合术（ACDF）器械在脊柱外科手术中很常见。这些器械位于椎间边缘内，可降低与颈椎前路钢板相关的风险，同时也能减少椎间融合器移位和下沉的风险。然而，这些器械的植入材料范围有限。因此，研发了一种无轮廓ACDF（npACDF）器械，其支撑着带有连接的负载分担固定界面的加工同种异体骨植入体。然而，该器械是否能支持早期机械稳定性及随后的骨融合，目前尚无文献报道。本研究的目的是在临床和临床前环境中评估该器械。
将24个功能性脊柱单元（FSU）分为4组（每组n = 6）。每组将接受一种单一的植入物：（1）带有连接的聚醚醚酮（PEEK）主体的npACDF器械，（2）带有连接的同种异体骨主体的npACDF器械，（3）带有未连接固定板的npACDF（同种异体骨主体）器械，以及（4）标准ACDF钢板和PEEK椎间融合器。FSU在完整状态下，然后在植入器械后，通过运动试验机进行纯力矩加载（屈伸、侧弯和轴向旋转）。记录椎体运动，并计算相对于完整状态的活动度（ROM）降低情况。对10例接受npACDF同种异体骨（连接）器械单节段ACDF治疗持续性颈椎神经根病或脊髓病的患者进行12个月的回顾性研究。报告影像学和患者报告的结果。
npACDF植入物之间的ROM无差异（P≥0.99）。标准ACDF在所有方向上的ROM降低均比npACDF植入物更多（P≥0.04）。所有受试者在12个月时均实现融合。
与传统钢板相比，npACDF同种异体骨器械的活动度降低较少；然而，病例系列数据表明该器械提供了临床上有效的稳定性，从而实现了高质量的影像学融合和疼痛改善。
本报告提供了对一种器械的临床和临床前见解，该器械具有与传统连续/刚性ACDF器械设计不同的设计特点。
