Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.
Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire.
J Bone Joint Surg Am. 2019 Feb 20;101(4):338-352. doi: 10.2106/JBJS.18.00483.
The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.
Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.
Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.
On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.
Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
对于初次就诊（无先前融合）的成人腰椎侧凸，与非手术治疗相比，手术治疗的效果尚未在对照试验中得到评估。本研究的目的是评估手术和非手术治疗的效果，并评估这些治疗方法的益处，以帮助治疗医生确定患者是通过手术还是非手术治疗更好地管理。
来自 9 个北美的中心的患有成人症状性腰椎侧凸的患者（年龄 40 至 80 岁，冠状 Cobb 角测量值≥30°，Oswestry 残疾指数[ODI]评分≥20 或 Scoliosis Research Society[SRS]-22 评分≤4.0）被纳入同期随机或观察队列，以评估手术与非手术治疗。主要结局是 2 年随访时 SRS-22 亚评分和 ODI 的平均变化。对于随机队列，最初的样本量计算估计每组 41 例（总计 82 例），将以 80%的效能和α值为 0.05 进行计算，预计非手术组的随访丢失率为 10%，不依从率为 20%。然而，中期样本量计算估计每组 18 例即可。
63 例患者被纳入随机队列：手术组 30 例，非手术组 33 例。223 例患者被纳入观察队列：手术组 112 例，非手术组 111 例。随机队列的意向治疗分析发现，2 年随访时，两组之间的结果没有差异。随机队列的不依从率很高（非手术组到手术组的交叉率为 64%）。在随机队列的治疗分析中，手术治疗在 2 年随访时与 SRS-22 亚评分（调整平均差异，0.7[95%置信区间（CI），0.5 至 1.0]）和 ODI（调整平均差异，-16[95%CI，-22 至-10]）的改善更大（p<0.001）。基于 SRS-22 亚评分和 ODI 结果，在治疗后 2 年的观察队列中，手术治疗也优于非手术治疗（p<0.001）。在整体应答者分析中，更多的手术患者在 SRS-22 亚评分（85.7%比 38.7%；p<0.001）和 ODI（77.4%比 38.3%；p<0.001）中达到符合或超过最小临床重要差异（MCID）的改善。在 24 名（14%）手术患者中进行了 34 次翻修手术。
基于治疗分析和 MCID 分析，如果患有成人症状性腰椎侧凸的患者对当前的脊柱相关健康状况感到满意，建议进行非手术治疗，同时要认识到改善的可能性不大。如果患者对当前的脊柱健康状况不满意并期望改善，手术是首选。
治疗性 II 级。有关完整的证据水平说明，请参见作者说明。
