From Kysthospitalet in Hagevik, Orthopedic Department, Haukeland University Hospital (I.M.A., E.H., F.R., K.I.), and the Department of Clinical Medicine, University of Bergen (E.H., F.R., K.I.), Bergen, Møre and Romsdal Hospital Trust, Ålesund Hospital, Orthopedic Department, Ålesund (E.H.), the Oslo Center for Biostatistics and Epidemiology, Research Support Services (M.W.F.), the Research and Communication Unit for Musculoskeletal Health, Division of Clinical Neuroscience (K.S.), and the Department of Physical Medicine and Rehabilitation (J.I.B.), Oslo University Hospital, the Department of Physiotherapy, Oslo Metropolitan University (K.S.), the Medical Faculty (J.I.B.), the Division of Radiology and Nuclear Medicine, Institute of Clinical Medicine, Faculty of Medicine (T.B.), and the Institute of Clinical Medicine (H. Banitalebi), University of Oslo, Akershus University Hospital, Orthopedic Department (O.G.), Radiology, Unilabs Radiology (K.R.H.A.), and the Department of Radiology and Nuclear Medicine (T.B.) and the Division of Orthopedic Surgery (C.H.), Oslo University Hospital Ullevål, Oslo, the Institute of Clinical Medicine, University of Tromsø-the Arctic University of Norway, and the Norwegian Registry for Spine Surgery, University Hospital of North Norway, Tromsø (T.S.), the Orthopedic Department (E.F.) and the Department of Neurosurgery (C.W.), Stavanger University Hospital, and the Department of Quality and Health Technology, Faculty of Health Sciences, University of Stavanger (C.W.), Stavanger, and the Department of Diagnostic Imaging, Akershus University Hospital, Lorenskog (H. Banitalebi) - all in Norway; and the Spine Surgery Team, Department of Orthopedics, Sahlgrenska University Hospital, and the Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (H. Brisby).
N Engl J Med. 2021 Aug 5;385(6):526-538. doi: 10.1056/NEJMoa2100990.
In patients with lumbar spinal stenosis and degenerative spondylolisthesis, it is uncertain whether decompression surgery alone is noninferior to decompression with instrumented fusion.
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.
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.
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. (NORDSTEN-DS ClinicalTrials.gov number, NCT02051374.).
对于患有腰椎管狭窄症和退行性腰椎滑脱的患者，单独减压是否不如减压联合器械融合术尚不确定。
我们进行了一项开放标签、多中心、非劣效性试验，纳入了对保守治疗无反应且单节段滑脱程度为 3 毫米或以上的有症状腰椎狭窄症患者。患者以 1:1 的比例随机分配接受减压手术（减压组）或减压联合器械融合术（融合组）。主要结局是术后 2 年内 Oswestry 功能障碍指数（ODI；范围为 0 到 100，分数越高表示功能障碍越严重）至少降低 30%，非劣效性边界为-15 个百分点。次要结局包括 ODI 评分的平均变化以及苏黎世间歇性跛行问卷、腿痛和腰痛、手术时间和住院时间、以及 2 年内再次手术的情况。
患者的平均年龄约为 66 岁。约 75%的患者腿痛持续超过 1 年，超过 80%的患者腰痛持续超过 1 年。减压组和融合组在基线至 2 年时 ODI 评分的平均变化分别为-20.6 和-21.3（平均差值，0.7；95%置信区间 [CI]，-2.8 至 4.3）。在改良意向治疗分析中，减压组 133 例患者中有 95 例（71.4%）和融合组 129 例患者中有 94 例（72.9%）ODI 评分至少降低了 30%（差值，-1.4 个百分点；95%CI，-12.2 至 9.4），表明单独减压具有非劣效性。在方案设定的分析中，减压组 106 例患者中有 80 例（75.5%）和融合组 110 例患者中有 83 例（75.5%）ODI 评分至少降低了 30%（差值，0.0 个百分点；95%CI，-11.4 至 11.4），表明具有非劣效性。次要结局的结果总体上与主要结局一致。在 2 年时可获得影像学结果的 100 例患者中，有 86 例（86.0%）确定融合成功。减压组有 15 例（12.5%）和融合组有 11 例（9.1%）患者进行了再次手术。
在这项涉及退行性腰椎滑脱症手术患者的试验中，大多数患者的症状持续超过 1 年，在 2 年内，单纯减压与减压联合器械融合术的效果相当。减压组的再次手术发生率略高于融合组。（NORDSTEN-DS ClinicalTrials.gov 编号，NCT02051374）。
