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2025年国际腰椎研究学会临床科学奖:一项关于三种不同微创减压技术治疗腰椎管狭窄症的随机试验。来自NORDSTEN-SST的五年随访

ISSLS Prize in Clinical Science 2025: A randomized trial on three different minimally invasive decompression techniques for lumbar spinal stenosis. Five years follow-up from the NORDSTEN-SST.

作者信息

Hermansen Erland, Indrekvam Kari, Franssen Eric, Myklebust Tor Åge, Austevoll Ivar Magne, Hellum Christian, Storheim Kjersti, Bånerud Ingrid Fjeldheim, Ebbs Eira Kathleen, Aaen Jørn, Banitalebi Hasan, Brox Jens Ivar, Weber Clemens, Solberg Tore, Hjulstad Arild, Brisby Helena

机构信息

Helse Møre Og Romsdal HF, Molde, Norway.

Norwegian University of Science and Technology, Trondheim, Norway.

出版信息

Eur Spine J. 2025 May;34(5):1590-1599. doi: 10.1007/s00586-024-08514-0. Epub 2024 Oct 24.

Abstract

PURPOSE

The short-term clinical outcome for midline-preserving posterior decompression techniques was comparable. The aim of this study was to evaluate long-term clinical results after three different midline-preserving posterior decompression techniques.

MATERIAL

In the NORDSTEN spinal stenosis trial (NORDSTEN-SST) 437 patients were randomized to three different midline-retaining posterior decompression techniques: Unilateral laminotomy with crossover (UL), bilateral laminotomy (BL) and spinous process osteotomy (SPO). Primary outcome was the mean change in Oswestry disability index (ODI) score at five-years follow-up. Secondary outcomes were the proportion of patients classified as success, mean change in EQ-5D, ZCQ-score, NRS-score for leg and low back pain, a seven-point Global Perceived Effect (GPE) Scale and proportion of subsequential spinal surgery.

RESULTS

The number of patients that completed follow-up data after five years was 358 (82%): In the UL, BL and SPO group the numbers were 122, 119 and 117, respectively. Mean age at baseline was 66.7 (SD 8.2) years, mean BMI was 27.8 (SD 4.1), and 172/358 (48%) were female. In the UL group the mean change was  -18.2 (95% CI  -21.0  -5.4), in the BL group it was  -19.0 (95% CI -21.9-16.1) and in the SPO it was  -18.6 (95% CI  -21.6-15.7) (p = 0.917). No significant differences in the secondary outcomes between the three surgical groups were found, also the subsequent spinal surgery rates were similar.

CONCLUSION

There were no significant differences in patient reported outcomes and subsequent spinal surgery rates after the three different decompression techniques at five-year follow-up.

摘要

目的

保留中线的后路减压技术的短期临床疗效相当。本研究的目的是评估三种不同的保留中线的后路减压技术后的长期临床结果。

材料

在NORDSTEN脊柱狭窄试验(NORDSTEN-SST)中,437例患者被随机分为三种不同的保留中线的后路减压技术:单侧椎板切开术交叉(UL)、双侧椎板切开术(BL)和棘突截骨术(SPO)。主要结局是五年随访时Oswestry功能障碍指数(ODI)评分的平均变化。次要结局包括被分类为成功的患者比例、EQ-5D的平均变化、ZCQ评分、腿部和下背部疼痛的NRS评分、七点整体感知效果(GPE)量表以及后续脊柱手术的比例。

结果

五年后完成随访数据的患者数量为358例(82%):在UL组、BL组和SPO组中,数量分别为122例、119例和117例。基线时的平均年龄为66.7(标准差8.2)岁,平均BMI为27.8(标准差4.1),172/358(48%)为女性。在UL组中,平均变化为-18.2(95%可信区间-21.0 -5.4),在BL组中为-19.0(95%可信区间-

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