Centro Hospitalar Universitário São João, Faculty of Medicine, University of Porto, Portugal; Department of Neurosurgery, Hull and East Yorkshire Hospitals NHS Trust, Anlaby Rd, Hull HU3 2JZ, United Kingdom.
Department of Orthopedic Surgery, National Health Insurance Service Ilsan Hospital, 100 Ilsan-ro, Ilsangdong-gu, Goyang-si, Gyeonggi, 410-719, South Korea.
Spine J. 2023 Oct;23(10):1494-1505. doi: 10.1016/j.spinee.2023.05.013. Epub 2023 May 25.
Several minimally invasive lumbar interbody fusion techniques may be used as a treatment for spondylolisthesis to alleviate back and leg pain, improve function and provide stability to the spine. Surgeons may choose an anterolateral or posterior approach for the surgery however, there remains a lack of real-world evidence from comparative, prospective studies on effectiveness and safety with relatively large, geographically diverse samples and involving multiple surgical approaches.
To test the hypothesis that anterolateral and posterior minimally invasive approaches are equally effective in treating patients with spondylolisthesis affecting one or two segments at 3-months follow-up and to report and compare patient reported outcomes and safety profiles between patients at 12-months post-surgery.
Prospective, multicenter, international, observational cohort study.
Patients with degenerative or isthmic spondylolisthesis who underwent 1- or 2-level minimally invasive lumbar interbody fusion.
Patient reported outcomes assessing disability (ODI), back pain (VAS), leg pain (VAS) and quality of life (EuroQol 5D-3L) at 4-weeks, 3-months and 12-months follow-up; adverse events up to 12-months; and fusion status at 12-months post-surgery using X-ray and/or CT-scan. The primary study outcome is improvement in ODI score at 3-months.
Eligible patients from 26 sites across Europe, Latin America and Asia were consecutively enrolled. Surgeons with experience in minimally invasive lumbar interbody fusion procedures used, according to clinical judgement, either an anterolateral (ie, ALIF, DLIF, OLIF) or posterior (MIDLF, PLIF, TLIF) approach. Mean improvement in disability (ODI) was compared between groups using ANCOVA with baseline ODI score used as a covariate. Paired t-tests were used to examine change from baseline in PRO for both surgical approaches at each timepoint after surgery. A secondary ANCOVA using a propensity score as a covariate was used to test the robustness of conclusions drawn from the between group comparison.
Participants receiving an anterolateral approach (n=114) compared to those receiving a posterior approach (n=112) were younger (56.9 vs 62.0 years, p <.001), more likely to be employed (49.1% vs 25.0%, p<.001), have isthmic spondylolisthesis (38.6% vs 16.1%, p<.001) and less likely to only have central or lateral recess stenosis (44.9% vs 68.4%, p=.004). There were no statistically significant differences between the groups for gender, BMI, tobacco use, duration of conservative care, grade of spondylolisthesis, or the presence of stenosis. At 3-months follow-up there was no difference in the amount of improvement in ODI between the anterolateral and posterior groups (23.2 ± 21.3 vs 25.8 ± 19.5, p=.521). There were no clinically meaningful differences between the groups on mean improvement for back- and leg-pain, disability, or quality of life until the 12-months follow-up. Fusion rates of those assessed (n=158; 70% of the sample), were equivalent between groups (anterolateral, 72/88 [81.8%] fused vs posterior, 61/70 [87.1%] fused; p=.390).
Patients with degenerative lumbar disease and spondylolisthesis who underwent minimally invasive lumbar interbody fusion presented statistically significant and clinically meaningful improvements from baseline up to 12-months follow-up. There were no clinically relevant differences between patients operated on using an anterolateral or posterior approach.
几种微创腰椎体间融合技术可用于治疗脊椎滑脱症,以减轻腰背疼痛,改善功能并为脊柱提供稳定性。外科医生可能会选择前路或后路进行手术,但在涉及多个手术入路的较大、地理分布广泛的样本中,仍缺乏来自比较、前瞻性研究的关于有效性和安全性的真实世界证据。
检验以下假设,即在 3 个月随访时,前路和后路微创入路治疗影响 1 或 2 个节段的脊椎滑脱症患者的效果相当,并报告和比较患者在手术后 12 个月的报告结果和安全性概况。
前瞻性、多中心、国际、观察性队列研究。
接受 1 或 2 节段微创腰椎体间融合术的退行性或峡部裂性脊椎滑脱症患者。
在 4 周、3 个月和 12 个月随访时评估患者报告的结果,包括残疾(ODI)、腰背疼痛(VAS)、下肢疼痛(VAS)和生活质量(EuroQol 5D-3L);在 12 个月时记录不良事件;使用 X 射线和/或 CT 扫描评估术后 12 个月的融合状态。主要研究结局是 3 个月时 ODI 评分的改善。
从欧洲、拉丁美洲和亚洲的 26 个地点连续纳入符合条件的患者。具有微创腰椎体间融合术经验的外科医生根据临床判断,分别采用前路(即 ALIF、DLIF、OLIF)或后路(MIDLF、PLIF、TLIF)入路。使用基线 ODI 评分作为协变量的协方差分析比较两组之间残疾(ODI)的平均改善情况。使用配对 t 检验在每个手术时间点检查两组的 PRO 从基线开始的变化。使用倾向评分作为协变量的二次协方差分析用于测试从组间比较得出的结论的稳健性。
接受前路入路的患者(n=114)与接受后路入路的患者(n=112)相比,年龄更小(56.9 岁 vs 62.0 岁,p<.001),更有可能就业(49.1% vs 25.0%,p<.001),患有峡部裂性脊椎滑脱症(38.6% vs 16.1%,p<.001),而仅有中央或侧方狭窄的可能性较小(44.9% vs 68.4%,p=.004)。两组之间在性别、BMI、吸烟、保守治疗持续时间、脊椎滑脱程度或狭窄存在方面没有统计学上的显著差异。在 3 个月随访时,前路和后路组的 ODI 改善量没有差异(23.2 ± 21.3 vs 25.8 ± 19.5,p=.521)。直到 12 个月随访时,两组在腰背疼痛、残疾或生活质量的平均改善方面都没有明显的差异。评估的融合率(n=158;样本的 70%)在两组之间是相当的(前路,72/88 [81.8%]融合 vs 后路,61/70 [87.1%]融合;p=.390)。
接受微创腰椎体间融合术的退行性腰椎疾病和脊椎滑脱症患者,从基线到 12 个月随访时,均有统计学显著和临床有意义的改善。前路和后路入路治疗的患者之间没有临床相关差异。