Goldman Samuel N, Paschal Gregory K, Mani Kyle, Abel Frederik, Avrumova Fedan, Sama Andrew A, Cammisa Frank P, Abjornson Celeste
Department of Spine Surgery, Integrated Spine Research Program, Hospital for Special Surgery, New York, NY, USA.
Albert Einstein College of Medicine, Bronx, NY, USA.
J Spine Surg. 2024 Sep 23;10(3):372-385. doi: 10.21037/jss-23-142. Epub 2024 Aug 7.
The predominant surgical procedure employed for patients with symptomatic cervical radiculopathy is anterior cervical discectomy and fusion (ACDF). ACDF typically involves the use of an interbody cage augmented with iliac crest bone graft (ICBG) or local autograft to enhance fusion rate. Substantial complications can arise from autograft use, including donor site morbidity, difficulties with ambulation, and diminished quality of life. This study aims to evaluate the effectiveness and safety of an allograft cellular bone matrix (ACBM) as an osteopromotive bone, in ACDF procedures.
This retrospective, single-center, consecutive case series included 73 patients who underwent an ACDF procedure. The surgical procedure involved the placement of an interbody cage supplemented with anterior plate fixation and an ACBM within the interbody spacer. Patient charts were reviewed to gather demographic information, radiographic findings, as well as perioperative and post-operative complications. Radiographic fusion was assessed at 6 and 12 months by a blinded, musculoskeletal-trained radiologist and a board-certified spinal surgeon reviewer. Any discrepancies were settled by a third, senior reviewer. Complete fusion was defined as: evidence of bridging bone across the disc space on CT, angular motion <3 degrees, and translational motion <2 mm on lateral radiographs. Complications were analyzed at 6, 12, and 15+ months post-operatively to assess clinical outcomes and device performance.
A total of 73 patients (50 males, 23 females) with an average age of 54.6 (range, 31-77) years underwent an ACDF procedure between C3-T1 with an ACBM. The breakdown of levels operated on was 26%, 32%, 34%, and 8% for one, two, three, and four level procedures, respectively. There were three patients who received spinal injections for pain within the first year post-operatively. There were two patients who required secondary surgery within the first 12 months where supplemental posterior hardware was needed. Notably, there were no instances of cage subsidence, cage migration, cage/graft removal, or reoperation. There were no cases of chronic dysphasia. At 6 months, 45% of patients with available imaging demonstrated complete fusion, while 97.4% of patients with available imaging demonstrated complete fusion at 12 months.
At the 12-month follow-up, our study demonstrates a high fusion rate in a real-world population of up to 4 operative levels. There were no bone graft related complications or incidences of cage migration/subsidence. It is noteworthy that the study involved a significant number of multilevel cases (74% of cases). Despite this, our results align with historical fusion rates and provide support for the utilization of ACBMs as a fusion adjunct in ACDF procedures up to 4 levels.
对于有症状的神经根型颈椎病患者，主要的外科手术方法是颈椎前路椎间盘切除融合术（ACDF）。ACDF通常包括使用椎间融合器，并辅以髂嵴骨移植（ICBG）或局部自体骨移植，以提高融合率。使用自体骨会引发大量并发症，包括供区并发症、行走困难和生活质量下降。本研究旨在评估同种异体脱细胞骨基质（ACBM）作为促进骨生长的骨材料在ACDF手术中的有效性和安全性。
这项回顾性、单中心、连续病例系列研究纳入了73例行ACDF手术的患者。手术过程包括在椎间融合器内放置椎间融合器并辅以钢板固定和ACBM。查阅患者病历以收集人口统计学信息、影像学检查结果以及围手术期和术后并发症。由一名经过肌肉骨骼专业培训的盲法放射科医生和一名获得委员会认证的脊柱外科医生在6个月和12个月时评估影像学融合情况。如有任何差异，由第三位资深审阅者解决。完全融合的定义为：CT显示椎间盘间隙有桥接骨形成，侧位X线片上角度运动<3度，平移运动<2毫米。在术后6、12和15个月以上分析并发症，以评估临床结果和器械性能。
共有73例患者（50例男性，23例女性）平均年龄54.6岁（范围31 - 77岁）行C3 - T1节段的ACDF手术并使用了ACBM。单节段、双节段、三节段和四节段手术的手术节段分布分别为26%、32%、34%和8%。有3例患者在术后第一年内接受了脊髓注射止痛。有2例患者在术后12个月内需要二次手术，需要补充后路内固定。值得注意的是，没有发生椎间融合器下沉、椎间融合器移位、椎间融合器/移植物取出或再次手术的情况。没有慢性吞咽困难的病例。在6个月时，有影像学资料的患者中45%显示完全融合，而在12个月时，有影像学资料的患者中97.4%显示完全融合。
在12个月的随访中，我们的研究表明，在现实世界中，多达4个手术节段的患者融合率很高。没有与骨移植相关的并发症或椎间融合器移位/下沉的情况。值得注意的是，该研究涉及大量多节段病例（74%的病例）。尽管如此，我们的结果与既往融合率一致，并为在多达4个节段的ACDF手术中使用ACBM作为融合辅助材料提供了支持。
