挪威霍克兰大学医院Ivar M. Austevoll团队比较了退行性腰椎滑脱减压合并或不合并器械融合术的疗效。这一研究成果发表在2021年8月4日出版的《新英格兰医学杂志》上。

在腰椎管狭窄和退行性椎体滑脱患者中，尚不确定单纯减压手术是否优于器械融合减压术。

研究组进行了一项开放标签、多中心、非劣效性试验，招募保守治疗无效且单节段椎体滑脱3 mm以上的症状性腰椎管狭窄患者。将其按1:1随机分配，分别接受减压手术（单纯减压组）或器械融合减压手术（融合组）。主要结局为术后两年内Oswestry残疾指数评分至少下降30%（ODI，范围0-100，分数越高表示损伤越严重），非劣效边缘为15个百分点。次要结局包括ODI评分和苏黎世跛行问卷评分的平均变化，腿部和背部疼痛，手术时间和住院时间，以及2年内的再次手术。

患者平均年龄约66岁。大约75%的患者腿部疼痛超过一年，超过80%的患者背部疼痛超过一年。单纯减压组的ODI评分从基线到术后2年平均降低20.6分，融合组降低21.3分，差异不显著。在改良意向治疗分析中，单纯减压组133例患者中有95例（71.4%）的ODI评分至少降低了30%，融合组129例患者中有94例（72.9%），显示出非劣效性。

在按方案分析中，单纯减压组106名患者中有80名（75.5%）ODI评分至少降低了30%，融合组110名患者中有83名（75.5%），显示出非劣效性。两组的次要结局相比亦显示出非劣效性。在2年内接受影像学检查的100例患者中有86例（86.0%）成功实现融合。单纯减压组120例患者中有15例（12.5%）进行了再手术，融合组121例患者中有11例（9.1%）。

研究结果表明，对于因退行性腰椎滑脱且大多数症状超过1年而接受手术的患者，接受单纯减压术后2年的预后不逊于器械融合减压术。单纯减压组患者再手术比融合组更常见。

附：英文原文

Title: Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis

Author: Ivar M. Austevoll, M.D., Ph.D.,, Erland Hermansen, M.D., Ph.D.,, Morten W. Fagerland, Ph.D.,, Kjersti Storheim, P.T., Ph.D.,, Jens I. Brox, M.D., Ph.D.,, Tore Solberg, M.D., Ph.D.,, Frode Rekeland, M.D.,, Eric Franssen, M.D.,, Clemens Weber, M.D., Ph.D.,, Helena Brisby, M.D., Ph.D.,, Oliver Grundnes, M.D., Ph.D.,, Knut R.H. Algaard, M.D.,, Tordis Bker, M.D.,, Hasan Banitalebi, M.D.,, Kari Indrekvam, M.D., Ph.D.,, and Christian Hellum, M.D., Ph.D.

Issue&Volume: 2021-08-04

Abstract:

Background

In patients with lumbar spinal stenosis and degenerative spondylolisthesis, it is uncertain whether decompression surgery alone is noninferior to decompression with instrumented fusion.

Methods

We conducted an open-label, multicenter, noninferiority trial involving patients with symptomatic lumbar stenosis that had not responded to conservative management and who had single-level spondylolisthesis of 3 mm or more. Patients were randomly assigned in a 1:1 ratio to undergo decompression surgery (decompression-alone group) or decompression surgery with instrumented fusion (fusion group). The primary outcome was a reduction of at least 30% in the score on the Oswestry Disability Index (ODI; range, 0 to 100, with higher scores indicating more impairment) during the 2 years after surgery, with a noninferiority margin of 15 percentage points. Secondary outcomes included the mean change in the ODI score as well as scores on the Zurich Claudication Questionnaire, leg and back pain, the duration of surgery and length of hospital stay, and reoperation within 2 years.

Results

The mean age of patients was approximately 66 years. Approximately 75% of the patients had leg pain for more than a year, and more than 80% had back pain for more than a year. The mean change from baseline to 2 years in the ODI score was 20.6 in the decompression-alone group and 21.3 in the fusion group (mean difference, 0.7; 95% confidence interval [CI], 2.8 to 4.3). In the modified intention-to-treat analysis, 95 of 133 patients (71.4%) in the decompression-alone group and 94 of 129 patients (72.9%) in the fusion group had a reduction of at least 30% in the ODI score (difference, 1.4 percentage points; 95% CI, 12.2 to 9.4), showing the noninferiority of decompression alone. In the per-protocol analysis, 80 of 106 patients (75.5%) and 83 of 110 patients (75.5%), respectively, had a reduction of at least 30% in the ODI score (difference, 0.0 percentage points; 95% CI, 11.4 to 11.4), showing noninferiority. The results for the secondary outcomes were generally in the same direction as those for the primary outcome. Successful fusion was achieved with certainty in 86 of 100 patients (86.0%) who had imaging available at 2 years. Reoperation was performed in 15 of 120 patients (12.5%) in the decompression-alone group and in 11 of 121 patients (9.1%) in the fusion group.

Conclusions

In this trial involving patients who underwent surgery for degenerative lumbar spondylolisthesis, most of whom had symptoms for more than a year, decompression alone was noninferior to decompression with instrumented fusion over a period of 2 years. Reoperation occurred somewhat more often in the decompression-alone group than in the fusion group.

DOI: 10.1056/NEJMoa2100990

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2100990