Yanik Elizabeth L, Kelly Michael P, Lurie Jon D, Baldus Christine R, Shaffrey Christopher I, Schwab Frank J, Bess Shay, Lenke Lawrence G, LaBore Adam, Bridwell Keith H
1Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.
2Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire.
J Neurosurg Spine. 2020 Mar 6;33(1):17-26. doi: 10.3171/2020.1.SPINE191288.
Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.
Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).
Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.
Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.
成人症状性腰椎侧弯（ASLS）是一种常见且致残的疾病。ASLS-1研究是一项多中心双臂研究（包括随机分组和观察性队列），旨在探讨ASLS患者手术治疗和非手术治疗对健康相关生活质量的影响。ASLS-1研究的一个目标是确定可改变ASLS手术治疗效果的患者因素和影像学因素。
年龄在40至80岁之间的ASLS患者在北美9个中心被纳入随机分组和观察性队列。主要结局指标是从基线到2年随访时，脊柱侧凸研究学会22项问卷（SRS-22）子评分（SRS-SS）和奥斯维斯特里功能障碍指数（ODI）的平均变化差异。采用意向性分析方法对合并队列进行分析。所研究的因素是预先设定的，或通过回归树分析确定。对于每个潜在的效应修饰因素，使用临床相关临界值或通过回归树创建亚组。使用广义线性混合模型比较组内和组间变化的估计值。效应修饰因素定义为SRS-SS（0.4）和ODI（7）的治疗效应差异均大于最小可检测测量差异。
共纳入286例患者，256例（90%）完成了2年随访；171例接受手术治疗，115例接受非手术治疗。除骨盆入射角与腰椎前凸（PI-LL）匹配度接近正常（≤11°）的患者外，手术治疗在所有考虑的效应亚组中均优于非手术治疗。与非手术治疗相比，男性患者以及基线时PI-LL不匹配度更高（>11°）的患者在SRS-SS和ODI方面的手术治疗效果更好。没有其他影像学亚组与治疗效果相关。高体重指数、较低的社会经济地位和较差的心理健康状况与较差的预后无关。
在这项探索性分析中，许多先前与手术预后不良相关的因素，如心理健康状况差、社会经济地位低和高体重指数，在ASLS患者中与预后无关。PI-LL不匹配度较高的患者手术治疗后的改善程度确实高于脊柱排列正常的患者。总体而言，所考虑的因素中没有一个与手术治疗相比非手术治疗的预后更差相关。这些发现可能为未来ASLS治疗中与预后相关因素的前瞻性分析提供指导。
