Boody Barrett S, Lee Evan N, Sasso Willa R, Vinayek Sheetal, Demeter Jaclyn M, Sasso Rick C, Smucker Joseph D
Indiana Spine Group, Indianapolis, IN.
University of Pennsylvania, Philadelphia, PA.
Clin Spine Surg. 2020 Nov;33(9):E420-E425. doi: 10.1097/BSD.0000000000000954.
A retrospective review of a prospective, randomized control Food and Drug Administration (FDA) investigational device exemption trial comparing anterior cervical discectomy and fusion (ACDF) with Bryan cervical disc arthroplasty.
Determine the clinical significance of adjacent-level ossification disease (ALOD) on long-term functional outcomes after ACDF or arthroplasty.
ALOD occurs when the anterior longitudinal ligament and annulus adjacent to the index surgical level calcifies. As previously reported, ALOD happens more commonly after an arthrodesis than an arthroplasty. No investigation has previously examined 10-year clinical outcomes associated with ALOD.
Forty patients were included in the 10-year follow-up. The index level was radiographically blinded and the cephalad-adjacent level was evaluated for ALOD. These scores underwent statistical analysis to compare the 2 surgical groups (ACDF and arthroplasty) for differences in the development of ALOD at a decade follow-up. Two investigational groups, on the basis of a high or low ALOD score, then proceeded through statistical analysis to compare the functional outcomes of patients in each group.
Statistical evaluation of ALOD findings in patients from each surgical group found a significantly higher rate of high-grade ALOD in patients who underwent cervical arthrodesis with plate fixation compared with cervical arthroplasty (68.2% vs. 11.1%, P=0.0003). Functional outcomes of patients were also assessed at the 10-year mark and outcomes in patients with either high-grade or low-grade ALOD were compared. When stratified by high versus low-grade ALOD, no significant difference was found for Neck Disability Index (NDI) (P=0.6431), VAS-arm (P=0.4497), or VAS-neck (P=0.8700) scores between groups.
The present study suggests that there are no significant long-term functional outcome differences between patients with and without significant ALOD. Our findings suggest ALOD may be a radiographic finding that does not alter patient-reported outcomes.
Level III-therapeutic.
对一项前瞻性、随机对照的美国食品药品监督管理局（FDA）研究器械豁免试验进行回顾性分析，该试验比较了颈椎前路椎间盘切除融合术（ACDF）与Bryan颈椎间盘置换术。
确定相邻节段骨化疾病（ALOD）对ACDF或椎间盘置换术后长期功能结局的临床意义。
当与手术索引节段相邻的前纵韧带和纤维环钙化时，就会发生ALOD。如先前报道，ALOD在关节融合术后比在椎间盘置换术后更常见。此前尚无研究考察与ALOD相关的10年临床结局。
40例患者纳入10年随访。对手术索引节段进行影像学盲法评估，并对头侧相邻节段进行ALOD评估。对这些评分进行统计分析，以比较两个手术组（ACDF和椎间盘置换术）在10年随访时ALOD发生情况的差异。然后，根据ALOD评分高低将两个研究组进行统计分析，以比较每组患者的功能结局。
对每个手术组患者的ALOD结果进行统计评估发现，与颈椎间盘置换术相比，接受钢板固定颈椎融合术的患者中高级别ALOD的发生率显著更高（68.2%对11.1%，P=0.0003）。还在10年时评估了患者的功能结局，并比较了高级别或低级别ALOD患者的结局。按高级别与低级别ALOD分层时，两组之间的颈部功能障碍指数（NDI）（P=0.6431）、上肢视觉模拟评分（VAS-arm）（P=0.4497）或颈部VAS（P=0.8700）评分均未发现显著差异。
本研究表明，有明显ALOD和无明显ALOD的患者在长期功能结局方面无显著差异。我们的研究结果表明，ALOD可能是一种影像学表现，不会改变患者报告的结局。
三级治疗性。
