Objective To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis. Design Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS). Setting 16 public orthopaedic and neurosurgical clinics in Norway. Participants Patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level. Interventions Decompression surgery alone and decompression with additional instrumented fusion (1:1). Main outcome measures The primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a −15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire. Results From 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) −11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of −1.3 percentage points (95% CI −14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of −15%. The mean change in Oswestry disability index from baseline to five years was −17.8 in both groups (mean difference 0.02 (95% CI −3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively. Conclusions In participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups. Trial registration ClinicalTrials.gov [NCT02051374][1] All data requests should be submitted to ivar.magne.austevoll{at}helse-bergen.no for consideration. The NORDSTEN scientific board may grant access to anonymised data following a research protocol review. The statistical analysis plan can be found on the clinicaltrials.gov website: . [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02051374&atom=%2Fbmj%2F386%2Fbmj-2024-079771.atom

中文翻译：

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单独减压或融合减压治疗退行性腰椎滑脱 (Nordsten-DS)：随机、多中心、非劣效性试验的五年随访


目的 评估退变性腰椎滑脱患者初次手术五年后单纯减压是否不劣于器械融合减压。设计 随机、多中心、非劣效性试验 (Nordsten-DS) 的五年随访。在挪威设有16家公立骨科和神经外科诊所。参与者 年龄 18-80 岁、有症状的腰椎管狭窄且狭窄水平滑脱 3 毫米或以上的患者。干预措施 单独减压手术和附加器械融合减压（1:1）。主要结果指标 主要结果是 Oswestry 残疾指数从基线到五年随访期间降低了 30% 或更多。预定的非劣效性界限是满足主要结局的患者比例差异-15个百分点。次要结局包括 Oswestry 残疾指数的平均变化、苏黎世跛行问卷、腿部和背部疼痛数字评定量表以及 EuroQol Group 5 维度 (EQ-5D-3L) 问卷。结果从2014年2月12日至2017年12月18日，267名参与者被随机分配至单纯减压组（n=134）和器械融合减压组（n=133）。其中，230 人 (88%) 回答了五年问卷：减压组 121 人，融合组 109 人。基线平均年龄为 66.2 岁 (SD 7.6)，其中 69% 为女性。在对缺失数据进行多重插补的改良意向治疗分析中，单纯减压组 133 人中的 84 人（63%）和融合组 129 人中 81 人（63%）的病情减轻了至少 30%在Oswestry残疾指数中，相差0.4个百分点。 （95% 置信区间 (CI) -11.2 至 11.9）。 每个方案分析的结果分别为：单独减压组为 100 人中的 65 人（65%），融合组为 89 人中的 59 人（66%），差异为 -1.3 个百分点（95% CI -14.5 至 12.2） 。两个 95% CI 均高于预定的非劣效性界值 -15%。两组 Oswestry 残疾指数从基线到五年的平均变化均为 -17.8（平均差 0.02（95% CI -3.8 至 3.9））。其他次要结局的结果与主要结局的方向相同。随访两年至五年，减压组 123 人中有 6 人（5%）接受了新腰椎手术，融合组 113 人中有 11 人（10%）接受了新的腰椎手术，从基线到五年的随访总数分别为 129 人中的 21 人（16%）和 125 人中的 23 人（18%）。结论 在患有退行性脊椎滑脱的参与者中，初次手术五年后单纯减压并不劣于器械融合减压。随后在指数水平或邻近腰椎水平进行手术的比例在各组之间没有差异。试验注册 ClinicalTrials.gov [NCT02051374][1] 所有数据请求均应提交至 ivar.magne.austevoll{at}helse-bergen.no 供考虑。经过研究方案审查后，NORDSTEN 科学委员会可能会授予匿名数据的访问权限。统计分析计划可以在 ClinicalTrials.gov 网站上找到： 。 [1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02051374&atom=%2Fbmj%2F386%2Fbmj-2024-079771。原子