Peppers Timothy A, Bullard Dennis E, Vanichkachorn Jed S, Stanley Scott K, Arnold Paul M, Waldorff Erik I, Hahn Rebekah, Atkinson Brent L, Ryaby James T, Linovitz Raymond J
Seaside Spine Medical Associates, 320 Santa Fe Dr., Suite 300, Encinitas, CA, 92024, USA.
Triangle Neurosurgery, 1540 Sunday Dr., Raleigh, NC, 27607, USA.
J Orthop Surg Res. 2017 Apr 26;12(1):67. doi: 10.1186/s13018-017-0564-5.
Trinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures.
In a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months.
At both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates.
Patients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material.
Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938.
Trinity Evolution®（TE）是一种可行的同种异体骨细胞移植材料，先前已证明在单节段颈椎前路椎间盘切除融合术（ACDF）后具有较高的融合率且无安全相关问题。本前瞻性多中心临床研究旨在评估TE在接受双节段ACDF手术患者中的影像学和临床结果。
在一项前瞻性多中心研究中，40例在两个相邻椎体节段出现症状性颈椎退变的患者，在聚醚醚酮（PEEK）椎间融合器中使用TE自体移植替代物进行了器械辅助ACDF手术。在12个月时，由对临床结果不知情的小组通过动态运动平片和薄层CT多平面重建来评估影像学融合状态。融合成功的定义为角运动（≤4°）以及相邻椎体终板间存在桥接骨。临床疼痛和功能评估包括6个月和12个月时的颈部功能障碍指数（NDI）、视觉模拟量表（VAS）评估的颈部和手臂疼痛以及SF-36。
在6个月和12个月时，所有临床结果评分（SF-36、NDI和VAS疼痛）与基线值相比均有显著改善（p < 0.05）。没有归因于移植材料的不良事件或感染，没有患者需要翻修，与基线相比，任何时候的平均神经学评估均无显著下降。在12个月时，每个患者和每个节段的融合率分别为89.4%和93.4%。与无假关节危险因素的患者相比，对有假关节危险因素（当前或既往吸烟者、糖尿病患者或肥胖/极度肥胖者）的患者进行亚组分析显示融合率无显著差异。
接受双节段ACDF并使用TE联合PEEK椎间融合器和前路辅助固定的患者融合成功率高，且没有与移植材料相关的严重不良事件。
颈椎前路椎间盘切除融合术（ACDF）中的Trinity Evolution，NCT00951938。
