Zuckerman Scott L, Cerpa Meghan, Lenke Lawrence G, Shaffrey Christopher I, Carreon Leah Y, Cheung Kenneth M C, Kelly Michael P, Fehlings Michael G, Ames Christopher P, Boachie-Adjei Oheneba, Dekutoski Mark B, Kabeaish Khaled M, Lewis Stephen J, Matsuyama Yukihiro, Pellisé Ferran, Qiu Yong, Schwab Frank J, Smith Justin S
Columbia University Medical Center, New York, NY, USA.
Duke University Medical Center, Durham, NC, USA.
Global Spine J. 2022 Oct;12(8):1736-1744. doi: 10.1177/2192568220988276. Epub 2021 Feb 9.
Prospective cohort.
To prospectively evaluate PROs up to 5-years after complex ASD surgery.
The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures.
Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, < 0.001), SF36-PCS (31.5 vs. 38.8, < 0.001), SF36-MCS (44.9 vs. 49.1, = 0.009), SRS-22-total (2.78 vs. 3.61, < 0.001), NRS-back pain (5.70 vs. 2.95, < 0.001) and NRS leg pain (3.64 vs. 2.62, = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values ( > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without.
After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.
前瞻性队列研究。
前瞻性评估复杂青少年特发性脊柱侧弯（ASD）手术后长达5年的患者报告结局（PROs）。
Scoli-RISK-1研究纳入了来自15个中心的272例接受手术的ASD患者。纳入标准为Cobb角>80°、先天性或翻修畸形的矫正截骨术和/或三柱截骨术。在术后长达5年的时间间隔内，前瞻性测量以下PROs：脊柱功能障碍指数（ODI）、健康调查简表36-生理健康成分总结（SF36-PCS）/心理健康成分总结（SF36-MCS）、脊柱侧凸研究学会-22项问卷（SRS-22）、数字评定量表（NRS）背部/腿部疼痛评分。在有5年随访数据的患者中，比较了从基线和术后2年到术后5年的数据。使用重复测量的混合模型分析PROs。
77例患者（28.3%）有5年随访数据。比较这77例患者的基线数据和5年数据，所有PROs均有显著改善：ODI（45.2对29.3，<0.001）、SF36-PCS（31.5对38.8，<0.001）、SF36-MCS（44.9对49.1，=0.009）、SRS-22总分（2.78对3.61，<0.001）、NRS背部疼痛评分（5.70对2.95，<0.001）和NRS腿部疼痛评分（3.64对2.62，=0.017）。在术后2至5年的随访期内，任何PROs均无显著变化。从基线到5年达到最小临床重要差异（MCID）的患者百分比为：ODI（62.0%）以及SRS-22r功能领域（70.4%）、疼痛（63.0%）、心理健康（37.5%）、自我形象（60.3%）和总分（60.3%）。令人惊讶的是，与无重大手术相关并发症的患者相比，有重大手术相关并发症的患者的平均值（>0.05）和达到MCID的比例没有显著差异。
复杂ASD手术后，术后5年时ODI、SF36-PCS/MCS、SRS-22r以及NRS背部/腿部疼痛的PROs有显著改善。术后2至5年期间PROs无显著变化。有重大手术相关并发症的患者与无这些并发症的患者的PROs及达到MCID的患者比例相似。
