Department of Orthopaedic and Trauma Research, Graduate School, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
Department of Orthopaedics, Ome Municipal General Hospital, 4-16-5 Higashiome, Ome-shi, Tokyo 198-0042, Japan.
Spine J. 2022 May;22(5):747-755. doi: 10.1016/j.spinee.2021.12.014. Epub 2021 Dec 25.
Lumbar canal stenosis due to degenerative lumbar spondylolisthesis is one of the most common indications for lumbar spinal surgery. However, from a long-term perspective, it is still unclear which of these procedures should be performed: decompression, decompression plus fusion, or decompression plus stabilization.
This study aimed to present the long-term results of a randomized controlled trial of surgery for degenerative spondylolisthesis.
STUDY DESIGN/SETTING: This is a long-term follow-up of a previously reported randomized controlled trial.
Patients aged ≤75 years with single L4/5 level lumbar canal stenosis caused by degenerative lumbar spondylolisthesis were enrolled at two hospitals from May 1, 2003, to April 30, 2012; the final follow-up was on May 20, 2021.
The following data were collected: modified Japanese Orthopedic Association (JOA) score, visual analog scale (VAS) score for lower back pain, leg pain, and numbness, and scores from eight Short-Form 36 (SF-36) subscales preoperatively, 1 year postoperatively, 5 years postoperatively, and at the final follow-up.
Patients were randomized to undergo decompression alone, decompression plus fusion, or decompression plus stabilization. The primary outcome measure was the change in VAS for lower back pain with secondary outcomes including the modified JOA score, VAS for leg pain, VAS for leg numbness, eight SF-36 subscale scores, and occurrence of reoperation at the last follow-up.
Among 85 patients who were randomized, 66 responded to the current survey. The mean follow-up period was 12.3 years. The VAS score for low back pain improvement was not significantly different between the decompression and fusion groups at the mean follow-up of 12.3 years. Of the 12 secondary outcomes, 8 showed no significant difference between decompression and fusion, 12 showed no significant difference between decompression and stabilization, and 10 showed no significant difference between fusion and stabilization.
Although additional instrumentation surgery did not significantly improve low back pain at the mean follow-up of 12.3 years compared with decompression alone, fusion surgery provided clinically meaningful improvements in patient-reported vitality, social functioning, role limitations due to personal or emotional problems, and mental health compared with decompression alone.
UMIN000028114.
退变性腰椎滑脱导致的腰椎管狭窄症是腰椎脊柱手术最常见的适应证之一。然而，从长期来看，仍不清楚应进行哪种手术：减压、减压加融合，还是减压加稳定。
本研究旨在介绍退行性脊柱滑脱症手术的随机对照试验的长期结果。
研究设计/设置：这是先前报告的一项随机对照试验的长期随访。
2003 年 5 月 1 日至 2012 年 4 月 30 日，在两家医院招募了年龄≤75 岁、由退变性腰椎滑脱引起的单节段 L4/5 水平腰椎管狭窄症患者；最终随访于 2021 年 5 月 20 日进行。
收集改良日本骨科协会（JOA）评分、下腰痛、腿痛和麻木的视觉模拟量表（VAS）评分，以及术前、术后 1 年、术后 5 年和最终随访时的 8 个简明健康调查问卷 36 项（SF-36）子量表评分。
患者被随机分为单独减压组、减压加融合组或减压加稳定组。主要观察指标是下腰痛 VAS 评分的变化，次要结局包括改良 JOA 评分、腿痛 VAS 评分、腿麻 VAS 评分、8 个 SF-36 子量表评分以及末次随访时的再手术发生率。
在 85 名随机分组的患者中，有 66 名对本次调查做出了回应。平均随访时间为 12.3 年。在平均随访 12.3 年后，减压与融合组之间的下腰痛 VAS 评分改善无显著差异。在 12 项次要结局中，8 项在减压与融合之间无显著差异，12 项在减压与稳定之间无显著差异，10 项在融合与稳定之间无显著差异。
与单纯减压相比，尽管额外的器械手术在平均 12.3 年的随访中并未显著改善腰痛，但与单纯减压相比，融合手术在患者报告的活力、社会功能、因个人或情绪问题导致的角色受限以及心理健康方面提供了有临床意义的改善。
UMIN000028114。
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