Feng Shang-Wen, Chang Ming-Chau, Chou Po-Hsin, Lin Hsi-Hsien, Wang Shih-Tien, Liu Chien-Lin
Department of Orthopedics and Traumatology, Taipei Veterans General Hospital, No. 201, Section 2, Shi-pai Road, Taipei, 11217, Taiwan, ROC.
School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.
Eur Spine J. 2018 Jun;27(6):1358-1364. doi: 10.1007/s00586-017-5450-7. Epub 2018 Jan 10.
To compare the clinical outcomes, radiographic results and fusion rate of ACDF between empty PEEK cages and PEEK cages packed with β-tricalcium phosphate.
Forty-five patients were prospectively enrolled with cervical degenerative disc disease who requiring ACDF with a PEEK cage. 23 patients were randomised to the study group (empty cages) and 22 patients were in the control group (cages filled with β-tricalcium phosphate). Both patient groups were fixed with a cervical locking plate. A CT scan was performed 12 months postoperatively and 24 months if not confirmed fused at 12 months to evaluate the status of fusion. Clinical status was evaluated using the Japanese Orthopaedic Association (JOA) score, the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS).
46 levels (97.88%) in the study group and 44 levels (97.77%) in the control group were confirmed as fused at 24 months. There was no significant difference between the fusion rates observed in the study and control groups (p = 0.82). There was no significant difference in JOA, ODI, or VAS scores at 24 months follow-up. The results showed that the members of the non-fusion group tended to be older than the individuals in the fusion group at 12 months, but was not significant in statistics.
Similar fusion rates and clinical outcomes were achieved when using ACDF with PEEK cages and instrumentation, regardless of whether the cage was filled with bone substitute at 24 months follow-up. Fusion rates improved over time and are comparable between both groups. These slides can be retrieved under Electronic Supplementary material.
比较单纯聚醚醚酮（PEEK）椎间融合器与填充β-磷酸三钙的PEEK椎间融合器在颈椎前路椎间盘切除融合术（ACDF）中的临床疗效、影像学结果和融合率。
前瞻性纳入45例因颈椎退行性椎间盘疾病需要行ACDF并使用PEEK椎间融合器的患者。23例患者被随机分配至研究组（单纯椎间融合器），22例患者被分配至对照组（填充β-磷酸三钙的椎间融合器）。两组患者均使用颈椎锁定钢板固定。术后12个月进行CT扫描，若12个月时未确认融合，则在24个月时进行CT扫描以评估融合状态。使用日本骨科协会（JOA）评分、Oswestry功能障碍指数（ODI）和视觉模拟量表（VAS）评估临床状态。
研究组46个节段（97.88%）和对照组44个节段（97.77%）在24个月时被确认为融合。研究组和对照组观察到的融合率之间无显著差异（p = 0.82）。在24个月随访时，JOA、ODI或VAS评分无显著差异。结果显示，在12个月时，未融合组的患者往往比融合组的患者年龄更大，但在统计学上不显著。
在24个月随访时，无论椎间融合器是否填充骨替代物，使用ACDF联合PEEK椎间融合器及内固定时均能获得相似的融合率和临床疗效。融合率随时间提高，且两组之间具有可比性。这些幻灯片可在电子补充材料中获取。
