Sinigaglia Riccardo, Bundy Albert, Costantini Sandro, Nena Ugo, Finocchiaro Francesco, Monterumici Daniele A Fabris
Spine Surgery Unit, Padua University Hospital, via Giustiniani 1, Padua 35128, Italy.
Eur Spine J. 2009 Jun;18 Suppl 1(Suppl 1):52-63. doi: 10.1007/s00586-009-0992-y. Epub 2009 Apr 29.
The aim of our prospective non-randomized clinical study was to analyze operative data, short-term results, safety, efficacy, complications, and prognostic factors for single-level total lumbar disc replacement (TLDR), and to compare results between different levels (L4-L5 vs. L5-S1). Thirty-six patients with single-level L4-L5 or L5-S1 TLDR, with 1-year minimum follow-up (FU), had complete clinical [SF36, visual analog scale (VAS), Oswestry Disability Index (ODI)] and radiological data, and were included in our study. Mean FU was 38.67 +/- 17.34 months. Replaced level was L4-L5 in 12 (33.3%) cases, and L5-S1 in 24 cases (66.7%). Mean age at diagnosis was 41.17 +/- 7.14 years. 24 (66.7%) were females and 12 (33.3%) were males. Statistical analyses were assessed using t tests or Mann-Whitney test for continuous variables and Chi-square test or Fisher's exact test analyses for categorical variables. Univariate linear regression and binary logistic regression analyses were utilized to evaluate the relationship between surgical outcomes and covariates (gender, age, etiology, treated level, pre-operative SF36, ODI, and VAS). Mean operative time was 147.03 +/- 30.03 min. Mean hospital stay was 9.69 +/- 5.39 days, and mean return to ambulation was 4.31 +/- 1.17 days. At 1-year FU, patients revealed a statistical significant improvement in VAS pain (P = 0.000), ODI lumbar function (P = 0.000), and SF36 general health status (P = 0.000). Single-level TLDR is a good alternative to fusion for chronic discogenic low back pain refractory to conservative measures. Our study confirmed satisfactory clinical results for monosegmental L4-L5 and L5-S1 disc prosthesis, with no difference between the two different levels for SF36 (P = 0.217), ODI (P = 0.527), and VAS (P = 0.269). However, replacement of the L4-L5 disc is affected by an increased risk of complication (P = 0.000). There were no prognostic factors for intraoperative blood loss or return to ambulation. Age (P = 0.034) was the only prognostic factor for operative time. Hospital stay was affected by level (P = 0.036) and pre-op VAS (P = 0.006), while complications were affected by the level (P = 0.000) and pre-op ODI (P = 0.049). Complete pre-operative assessment (in particular VAS and ODI questionnaires) is important because more debilitating patients will have more hospital stay and higher complications or complaints. Patients had to be informed that complications, possibly severe, are particularly frequent (80.6%).
我们这项前瞻性非随机临床研究的目的是分析单节段全腰椎间盘置换术（TLDR）的手术数据、短期结果、安全性、疗效、并发症及预后因素，并比较不同节段（L4-L5与L5-S1）之间的结果。36例接受单节段L4-L5或L5-S1 TLDR且至少随访1年（FU）的患者，具备完整的临床[SF36、视觉模拟量表（VAS）、奥斯威斯利功能障碍指数（ODI）]和放射学数据，被纳入我们的研究。平均随访时间为38.67±17.34个月。置换节段为L4-L5的有12例（33.3%），L5-S1的有24例（66.7%）。诊断时的平均年龄为41.17±7.14岁。女性24例（66.7%），男性12例（33.3%）。连续变量采用t检验或曼-惠特尼检验进行统计分析，分类变量采用卡方检验或费舍尔精确检验分析。采用单变量线性回归和二元逻辑回归分析评估手术结果与协变量（性别、年龄、病因、治疗节段、术前SF36、ODI和VAS）之间的关系。平均手术时间为147.03±30.03分钟。平均住院时间为9.69±5.39天，平均恢复行走时间为4.31±1.17天。在1年随访时，患者的VAS疼痛（P = 0.000）、ODI腰椎功能（P = 0.000）和SF36总体健康状况（P = 0.000）有统计学显著改善。对于保守治疗无效的慢性椎间盘源性下腰痛，单节段TLDR是融合术的良好替代方案。我们的研究证实单节段L4-L5和L5-S1椎间盘假体的临床结果令人满意，SF36（P = 0.217）、ODI（P = 0.527）和VAS（P = 0.269）在两个不同节段之间无差异。然而，L4-L5椎间盘置换受并发症风险增加的影响（P = 0.000）。术中失血或恢复行走无预后因素。年龄（P = 0.034）是手术时间的唯一预后因素。住院时间受节段（P = 0.036）和术前VAS（P = 0.006）影响，而并发症受节段（P = 0.000）和术前ODI（P = 0.049）影响。完整的术前评估（尤其是VAS和ODI问卷）很重要，因为身体状况较差的患者住院时间会更长，并发症或不适也会更多。必须告知患者并发症（可能很严重）特别常见（80.6%）。
