Department of Orthopedics, Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, China.
Department of Orthopedics, The First People's Hospital of Shuangliu District, Chengdu, China.
Orthop Surg. 2023 Nov;15(11):2889-2900. doi: 10.1111/os.13896. Epub 2023 Sep 28.
The three-dimensional printing titanium (3DPT) cage with excellent biomechanical properties and osseointegration capabilities has been initially used in spinal fusion, while the polyetheretherketone (PEEK) cage, a bioinert material device, has been a widely used for decades with relatively excellent clinical outcomes. This study was performed to investigate the early radiographic and clinical outcomes of 3DPT cage versus PEEK cage in patients undergoing anterior cervical discectomy and fusion (ACDF) and transforaminal lumbar interbody fusion (TLIF).
This prospective controlled trial, from December 2019 to June 2022, included patients undergoing ACDF and TLIF with 3DPT cages and compared them to patients using PEEK cages for treating spinal degenerative disorders. The outcome measures included radiographic parameters (intervertebral height [IH], subsidence, fusion status, and bone-cage interface contact) and clinical outcomes (Japanese Orthopaedic Association [JOA], Neck Disability Index [NDI], Oswestry Disability Index [ODI], Short Form 12-Item Survey [SF-12], Visual Analog Scale [VAS], and Odom's criteria). Student's independent samples t test and Pearson's chi-square test were used to compare the outcome measures between the two groups before surgery and at 1 week, 3 and 6 months after surgery.
For the patients undergoing ACDF, the 3DPT (18 patients/[26 segments]) and PEEK groups (18 patients/[26 segments]) had similar fusion rates at 3 months and 6 months follow-up (3 months: 96.2% vs. 83.3%, p = 0.182; 6 months: 100% vs. 91.7%, p = 0.225). The subsidence in the 3DPT group was significantly lower than that in the PEEK group (3 months: 0.4 ± 0.2 mm vs. 0.9 ± 0.7 mm p = 0.004; 6 months: 0.7 ± 0.3 mm vs. 1.5 ± 0.8 mm, p < 0.001). 3DPT and PEEK cage all achieved sufficient contact with the cervical endplates. For the patients undergoing TLIF, the 3DPT (20 patients/[26 segments]) and PEEK groups (20 patients/[24 segments]) had no statistical difference in fusion rate (3 months: 84.6% vs. 58.3%, p = 0.059; 6 months: 92.3% vs. 75%, p = 0.132). The subsidence was lower than that in the PEEK group without significantly difference (3 months: 0.9 ± 0.7 mm vs.1.2 ± 0.9 mm p = 0.136; 6 months: 1.6 ± 1.0 mm vs. 2.0 ± 1.0 mm, p = 0.200). At the 3-month follow-up, the bone-cage interface contact of the 3DPT cage was significantly better than that of the PEEK cage (poor contact: 15.4% vs. 75%, p < 0.001). The values of UAR were higher in the 3DPT group than in the PEEK group during the follow-up in cervical and lumbar fusion, there were more statistical differences in lumbar fusion. There were no significant differences in the clinical assessment between 3DPT or PEEK cage in spinal fusion.
The 3DPT cage and PEEK cage can achieve excellent clinical outcomes in cervical and lumbar fusion. The 3DPT cage has advantage in fusion quality, subsidence severity, and bone-cage interface contact than PEEK cage.
具有优异生物力学性能和骨整合能力的三维打印钛（3DPT）笼已初步应用于脊柱融合术，而聚醚醚酮（PEEK）笼作为一种生物惰性材料装置，已广泛应用数十年，具有相对优异的临床效果。本研究旨在探讨 3DPT 笼与 PEEK 笼在前路颈椎间盘切除融合术（ACDF）和经椎间孔腰椎体间融合术（TLIF）患者中的早期影像学和临床结果。
这是一项前瞻性对照试验，于 2019 年 12 月至 2022 年 6 月期间进行，纳入了使用 3DPT 笼和 PEEK 笼治疗脊柱退行性疾病的患者。比较了后路颈椎间盘切除融合术（ACDF）和经椎间孔腰椎体间融合术（TLIF）患者的影像学参数（椎间高度[IH]、下沉、融合状态和骨笼界面接触）和临床结果（日本矫形协会[JOA]评分、颈部残疾指数[NDI]、Oswestry 残疾指数[ODI]、SF-12 短格式 12 项调查[SF-12]、视觉模拟量表[VAS]和 Odom 标准）。在手术前和手术后 1 周、3 个月和 6 个月时，采用学生独立样本 t 检验和 Pearson 卡方检验比较两组间的结果指标。
对于接受 ACDF 的患者，3DPT（18 例/[26 个节段]）和 PEEK 组（18 例/[26 个节段]）在 3 个月和 6 个月随访时的融合率相似（3 个月：96.2%比 83.3%，p=0.182；6 个月：100%比 91.7%，p=0.225）。3DPT 组的下沉明显低于 PEEK 组（3 个月：0.4±0.2mm 比 0.9±0.7mm，p=0.004；6 个月：0.7±0.3mm 比 1.5±0.8mm，p<0.001）。3DPT 和 PEEK 笼均与颈椎终板有足够的接触。对于接受 TLIF 的患者，3DPT（20 例/[26 个节段]）和 PEEK 组（20 例/[24 个节段]）在融合率方面无统计学差异（3 个月：84.6%比 58.3%，p=0.059；6 个月：92.3%比 75%，p=0.132）。下沉低于 PEEK 组，但无统计学差异（3 个月：0.9±0.7mm 比 1.2±0.9mm，p=0.136；6 个月：1.6±1.0mm 比 2.0±1.0mm，p=0.200）。在 3 个月随访时，3DPT 笼的骨笼界面接触明显优于 PEEK 笼（接触不良：15.4%比 75%，p<0.001）。在颈椎和腰椎融合的随访过程中，3DPT 组的 UAR 值高于 PEEK 组，差异更具统计学意义。在脊柱融合的临床评估中，3DPT 或 PEEK 笼之间没有显著差异。
3DPT 笼和 PEEK 笼在颈椎和腰椎融合中均可取得优异的临床效果。3DPT 笼在融合质量、下沉严重程度和骨笼界面接触方面优于 PEEK 笼。
