挪威伯根毫克兰大学医院Ivar Magne Austevoll团队研究了单独减压术治疗退行性腰椎滑脱患者5年预后是否不亚于器械融合减压术。相关论文于2024年8月7日发表在《英国医学杂志》上。

为了评估退行性腰椎滑脱患者初次手术后五年，单独减压术是否不亚于器械融合减压术，研究组在挪威的16家公立骨科和神经外科诊所进行了一项随机、多中心、非劣效性试验（Nordsten DS）的五年随访。

参与者为年龄在18-80岁之间，有症状的腰椎管狭窄症和狭窄处椎体滑脱3毫米及以上的脊椎滑脱患者，将其随机分组，分别接受单独减压术和减压加器械融合术（1:1）。主要结局是Oswestry残疾指数从基线到五年随访降低了30%或更多。预定义的非劣效性界限是达到主要结局的患者比例相差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欧洲生活质量组5维（EQ-5D-3L）问卷。

2014年2月12日到2017年12月18日，267名参与者被随机分配到单独减压组（n=134）和器械融合减压组（n=133）。其中，230人（88%）对五年问卷做出了回应：减压组121人，融合组109人。基线时的平均年龄为66.2岁（标准差7.6），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，单独减压组133人中有84人（63%）和融合组129人中有81人（63%）的Oswestry残疾指数至少降低了30%，差异为0.4个百分点（95%置信区间（CI）11.2至11.9）。

单独减压组100例中有65例（65%）出现按方案分析的结果，融合组89例中有59例（66%），差异为1.3个百分点（95%CI 14.5至12.2）。95%置信区间均高于预定义的非劣效性界限15%。两组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））。其他次要结局与主要结局一致。从2年到5年的随访中，减压组123人中有6人（5%）和融合组113人中有11人（10%）进行了新的腰椎手术，从基线到5年，两组分别有129人中21人（16%）和125人中23人（18%）进行了手术。

研究结果表明，在退行性脊椎滑脱的参与者中，初次手术后五年，单独减压术并不逊于器械融合减压术。两组在指数水平或相邻腰椎水平的后续手术比例没有差异。

附：英文原文

Title: Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial

Author: Eric Loratang Kgomotso, Christian Hellum, Morten Wang Fagerland, Tore Solberg, Jens Ivar Brox, Kjersti Storheim, Erland Hermansen, Eric Franssen, Clemens Weber, Helena Brisby, Knut Robert Hector Algaard, Hvard Furunes, Hasan Banitalebi, Inger Ljstad, Kari Indrekvam, Ivar Magne Austevoll

Issue&Volume: 2024/08/07

Abstract:

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.

DOI: 10.1136/bmj-2024-079771

Source: https://www.bmj.com/content/386/bmj-2024-079771