National and Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, First Hospital Affiliated to Army Military University (Southwest Hospital), Chongqing, China.
National and Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, First Hospital Affiliated to Army Military University (Southwest Hospital), Chongqing, China.
World Neurosurg. 2019 Jun;126:e1309-e1314. doi: 10.1016/j.wneu.2019.03.084. Epub 2019 Mar 18.
We evaluated the clinical efficacy of the Biocage in lumbar fusion surgery and its safety and effectiveness.
A total of 431 patients with single-segment lumbar degenerative disease diagnosed from January 2013 to December 2016 were considered for the present prospective, nonrandomized, and controlled study; 52 patient met the exclusion criteria and were excluded. The patients were divided into 2 groups according to their cage choice: Biocage (n = 206) and polyether ether ketone (PEEK) cage (n = 173). The patients were followed up for 24-48 months (average, 32). The operative time, blood loss, hospitalization duration, mean intervertebral fusion segment height, height of intervertebral foramen, fusion time, fusion rate, internal fixation failure rate, visual analog scale score, and Oswestry disability index were compared between the 2 groups.
All the patients underwent surgery successfully. No significant differences were found in gender, age, clinical diagnosis, lesion segment, operative time, blood loss, visual analog scale score, or Oswestry disability index between the 2 groups. No significant differences were found in the fusion rate; however, the Biocage group had a greater fusion rate and shorter fusion time than the PEEK group. During follow-up, the mean intervertebral height recovered significantly in the Biocage group compared with the PPEK group (P < 0.05). The height of the intervertebral foramen was significantly different between the 2 groups, and recovery was better in the Biocage group (P < 0.05). The Cobb angle of fusion segment in both groups improved significantly postoperatively compared with preoperatively (P < 0.05). The improvement in Cobb angle was significantly different between the 2 groups (P < 0.05).
The Biocage has excellent clinical efficacy in the treatment of lumbar degenerative disease. Although the Biocage achieved good therapeutic effects, it did not show obvious advantages compared with the PEEK cage. Therefore, the Biocage can only be used as a choice of bone graft materials for lumbar fusion surgery and should not completely replace the PEEK cage.
评估 Biocage 在腰椎融合术中的临床疗效及其安全性和有效性。
本前瞻性、非随机、对照研究共纳入 2013 年 1 月至 2016 年 12 月期间诊断为单节段腰椎退变性疾病的 431 例患者；52 例患者因不符合纳入标准而被排除。根据所选椎间融合器的不同，将患者分为 Biocage 组（n=206）和聚醚醚酮（PEEK） cage 组（n=173）。对两组患者进行 24-48 个月（平均 32 个月）随访。比较两组患者的手术时间、出血量、住院时间、平均椎间融合节段高度、椎间孔高度、融合时间、融合率、内固定失败率、视觉模拟评分（VAS）和 Oswestry 功能障碍指数（ODI）。
所有患者均顺利完成手术。两组患者的性别、年龄、临床诊断、病变节段、手术时间、出血量、VAS 评分和 ODI 比较，差异均无统计学意义。两组患者的融合率比较，差异无统计学意义；但 Biocage 组的融合率高于 PEEK 组，融合时间短于 PEEK 组。随访时，Biocage 组的椎间高度恢复明显优于 PEEK 组（P<0.05）。两组患者的椎间孔高度比较，差异有统计学意义，Biocage 组恢复更好（P<0.05）。两组患者术后融合节段 Cobb 角均较术前明显改善（P<0.05），两组间改善程度比较，差异有统计学意义（P<0.05）。
Biocage 治疗腰椎退变性疾病具有良好的临床疗效。Biocage 虽然取得了良好的治疗效果，但与 PEEK cage 相比，并未显示出明显的优势，因此只能作为腰椎融合术骨移植材料的选择，不能完全替代 PEEK cage。
