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腰椎前路椎间融合术与全椎间盘置换术的长期疗效比较:一项平均随访14年的前瞻性随机对照试验

A comparison of the long-term results of anterior lumbar interbody fusion and total disc arthroplasty: a prospective randomized controlled trial with a mean follow-up of 14 years.

作者信息

Putzier Michael, Fussi Jasmin, Khakzad Thilo, Lindemann Chris, Zippelius Timo Karl, Strube Patrick

机构信息

Centre for Musculoskeletal Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.

Surgery and Musculoskeletal Sciences, Mediterranean Neurological Institute (IRCCS Neuromed), Pozzilli, Italy.

出版信息

Bone Joint J. 2025 Jun 1;107-B(6):639-648. doi: 10.1302/0301-620X.107B6.BJJ-2024-1646.R1.

Abstract

AIMS

This prospective randomized study compares the clinical and radiological long-term outcomes of single-level anterior lumbar interbody fusion (ALIF) and total disc arthroplasty (TDA).

METHODS

Patients with symptomatic single-level degenerative disc disease (DDD) at L4/5 or L5/S1 were randomly assigned to groups ALIF or TDA. Clinical evaluations using the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for pain were conducted preoperatively, at three, 12, and 24 months, and after a mean follow-up of 14 years (12.2 to 15.9). Radiological assessments included radiographs in two planes and flexion-extension views. Additionally, CT was performed in the ALIF group to evaluate fusion after 24 months. Complications and patient satisfaction were recorded. Outcomes were analyzed for the entire cohort and by spinal segment.

RESULTS

Of the 120 patients included (60 per group), 28 were lost to follow-up, including three excluded because of revision surgery. In the remaining patients, significant improvements in ODI and VAS were seen over time (all p < 0.001). Clinical scores had declined slightly by final follow-up but remained better than the preoperative levels. No significant overall differences were found between ALIF and TDA. However, subgroup analysis revealed that ALIF outperformed TDA at L5/S1 (ODI posthoc test at final follow-up p = 0.005): outcomes were comparable at L4/5.

CONCLUSION

Both ALIF and TDA are safe and effective methods of treating single-level DDD. ALIF is preferable at L5/S1 due to biomechanical factors, such as variability in the centre of rotation and sagittal profile types, which have a negative impact on the outcomes of TDA at this level. Conversely, at L4/5, both procedures give comparable results. These findings emphasize the importance of considering segment-specific anatomical and biomechanical factors in surgical decision-making for DDD.

摘要

目的

本前瞻性随机研究比较了单节段腰椎前路椎间融合术(ALIF)和全椎间盘置换术(TDA)的临床和影像学长期疗效。

方法

L4/5或L5/S1节段有症状的单节段退变性椎间盘疾病(DDD)患者被随机分为ALIF组或TDA组。术前、术后3个月、12个月和24个月以及平均随访14年(12.2至15.9年)时,使用Oswestry功能障碍指数(ODI)和视觉模拟疼痛量表(VAS)进行临床评估。影像学评估包括两个平面的X线片和屈伸位片。此外,对ALIF组在24个月后进行CT检查以评估融合情况。记录并发症和患者满意度。对整个队列和按脊柱节段分析结果。

结果

纳入的120例患者(每组60例)中,28例失访,其中3例因翻修手术被排除。在其余患者中,ODI和VAS随时间有显著改善(所有p<0.001)。末次随访时临床评分略有下降,但仍优于术前水平。ALIF和TDA之间未发现显著的总体差异。然而,亚组分析显示,在L5/S1节段ALIF的效果优于TDA(末次随访时ODI事后检验p = 0.005):在L4/5节段结果相当。

结论

ALIF和TDA都是治疗单节段DDD的安全有效方法。由于生物力学因素,如旋转中心的变异性和矢状面轮廓类型,会对该节段TDA的结果产生负面影响,因此在L5/S1节段ALIF更可取。相反,在L4/5节段,两种手术的结果相当。这些发现强调了在DDD手术决策中考虑节段特异性解剖和生物力学因素的重要性。

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