Abstract：
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.
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.
摘要：
背景：几种微创腰椎椎间融合技术可用作治疗腰椎滑脱的方法，以减轻背部和腿部疼痛，改善功能并为脊柱提供稳定性。然而，外科医生可以选择前外侧或后路手术，仍然缺乏来自比较的现实世界证据，关于有效性和安全性的前瞻性研究，不同地域的样本，涉及多种手术方法。
目的：验证前外侧和后外侧微创入路在3个月随访时对影响一个或两个节段的腰椎滑脱患者同样有效的假设，并报告和比较患者在术后12个月时报告的结果和安全性。
方法：前瞻性，多中心，国际,观察性队列研究。
方法：接受1级或2级微创腰椎椎间融合术的退行性或峡部滑脱患者。
方法：患者报告的结果评估残疾（ODI），背痛（VAS），4周时腿部疼痛（VAS）和生活质量（EuroQol5D-3L），3个月和12个月的随访;不良事件长达12个月;以及使用X射线和/或CT扫描在手术后12个月的融合状态。主要研究结果是3个月时ODI评分的改善。
方法：来自欧洲26个地点的合格患者，拉丁美洲和亚洲连续注册。具有微创腰椎椎间融合手术经验的外科医生，根据临床判断,前外侧(即，ALIF,DLIF,OLIF)或后部(MIDLF，PLIF,TLIF)方法。使用ANCOVA与基线ODI评分作为协变量比较两组间的平均残疾改善(ODI)。使用配对t检验来检查手术后每个时间点两种手术入路的PRO相对于基线的变化。使用倾向评分作为协变量的次要ANCOVA用于测试从组间比较得出的结论的稳健性。
结果：接受前外侧入路（n=114）的参与者与接受后入路（n=112）的参与者相比年轻（56.9岁vs62.0岁，p<.001),更有可能被雇用(49.1%对25.0%，p<.001),有峡部滑脱(38.6%vs16.1%，p<.001）且仅有中央或外侧隐窝狭窄的可能性较小（44.9%vs68.4%，p=.004）。两组性别之间没有统计学上的显着差异，BMI,烟草使用,保守护理的持续时间，脊椎滑脱等级,或者狭窄的存在。在3个月的随访中，前外侧和后外侧组之间的ODI改善量没有差异（23.2±21.3vs25.8±19.5，p=.521）。在背部和腿部疼痛的平均改善方面，两组之间没有临床意义的差异，残疾,或生活质量，直到12个月的随访。被评估者的融合率(n=158；样本的70%)，组间相当[前外侧，72/88（81.8%）与后融合，61/70（87.1%）融合；p=.390）。
结论：接受微创腰椎椎间融合术的退行性腰椎疾病和腰椎滑脱患者，从基线到12个月的随访，具有统计学意义和临床意义的改善。使用前外侧或后入路手术的患者之间没有临床相关差异。
目的：验证前外侧和后外侧微创入路在3个月随访时对影响一个或两个节段的腰椎滑脱患者同样有效的假设，并报告和比较患者在术后12个月时报告的结果和安全性。
方法：前瞻性，多中心，国际,观察性队列研究。
方法：接受1级或2级微创腰椎椎间融合术的退行性或峡部滑脱患者。
方法：患者报告的结果评估残疾（ODI），背痛（VAS），4周时腿部疼痛（VAS）和生活质量（EuroQol5D-3L），3个月和12个月的随访;不良事件长达12个月;以及使用X射线和/或CT扫描在手术后12个月的融合状态。主要研究结果是3个月时ODI评分的改善。
方法：来自欧洲26个地点的合格患者，拉丁美洲和亚洲连续注册。具有微创腰椎椎间融合手术经验的外科医生，根据临床判断,前外侧(即，ALIF,DLIF,OLIF)或后部(MIDLF，PLIF,TLIF)方法。使用ANCOVA与基线ODI评分作为协变量比较两组间的平均残疾改善(ODI)。使用配对t检验来检查手术后每个时间点两种手术入路的PRO相对于基线的变化。使用倾向评分作为协变量的次要ANCOVA用于测试从组间比较得出的结论的稳健性。
结果：接受前外侧入路（n=114）的参与者与接受后入路（n=112）的参与者相比年轻（56.9岁vs62.0岁，p<.001),更有可能被雇用(49.1%对25.0%，p<.001),有峡部滑脱(38.6%vs16.1%，p<.001）且仅有中央或外侧隐窝狭窄的可能性较小（44.9%vs68.4%，p=.004）。两组性别之间没有统计学上的显着差异，BMI,烟草使用,保守护理的持续时间，脊椎滑脱等级,或者狭窄的存在。在3个月的随访中，前外侧和后外侧组之间的ODI改善量没有差异（23.2±21.3vs25.8±19.5，p=.521）。在背部和腿部疼痛的平均改善方面，两组之间没有临床意义的差异，残疾,或生活质量，直到12个月的随访。被评估者的融合率(n=158；样本的70%)，组间相当[前外侧，72/88（81.8%）与后融合，61/70（87.1%）融合；p=.390）。
结论：接受微创腰椎椎间融合术的退行性腰椎疾病和腰椎滑脱患者，从基线到12个月的随访，具有统计学意义和临床意义的改善。使用前外侧或后入路手术的患者之间没有临床相关差异。
