目的:评估退变性腰椎滑脱患者初次手术后5年单纯减压是否不如器械融合减压。
方法:随机的五年随访,多中心,非劣效性试验(Nordsten-DS)。
方法:挪威的16个公共骨科和神经外科诊所。
方法:年龄在18-80岁的患者,有症状的腰椎管狭窄症和狭窄水平的腰椎滑脱3mm或以上。
方法:单纯减压手术和附加器械融合减压(1:1)。
方法:主要结果是Oswestry残疾指数从基线到五年随访降低30%或更多。预定义的非劣效性界限是满足主要结局的患者比例的差异-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,腿部和背部疼痛的数字评定量表,和EuroQol集团5维(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到单独减压(n=134)和器械融合减压(n=133)。其中,230(88%)回答了五年问卷:减压组121个,融合组109个。基线时的平均年龄为66.2岁(SD7.6),69%是女性。在对缺失数据进行多重填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人中的81人(63%)Oswestry残疾指数至少降低了30%,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是减压组100个中的65个(65%)和融合组89个中的59个(66%),差异为-1.3个百分点(95%CI-14.5至12.2)。95%CI均高于预定义的非劣效性界限-15%。两组中Oswestry残疾指数从基线到五年的平均变化为-17.8(平均差异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。从两到五年的随访,减压组123人中有6人(5%)和融合组113人中有11人(10%)发生了新的腰椎手术,从基线到五年的总数分别为129人中的21人(16%)和125人中的23人(18%)。
结论:在退行性腰椎滑脱患者中,初次手术后五年,单纯减压不劣于器械融合减压。两组之间在索引水平或相邻腰椎水平的后续手术比例没有差异。
背景:ClinicalTrials.govNCT02051374。
To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.
Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).
16 public orthopaedic and neurosurgical clinics in Norway.
Patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level.
Decompression surgery alone and decompression with additional instrumented fusion (1:1).
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.
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.
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.
ClinicalTrials.gov NCT02051374.