Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale.
Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale.
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DOI：
10.1227/neu.0000000000000479
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发表时间：
2014-10
期刊：
影响因子：
4.8
通讯作者：
Schwartz JS
中科院分区：
文献类型：
--
作者：
Ghogawala Z;Benzel EC;Heary RF;Riew KD;Albert TJ;Butler WE;Barker FG 2nd;Heller JG;McCormick PC;Whitmore RG;Freund KM;Schwartz JS
脊髓型颈椎病（CSM）是世界上最常见的脊髓功能障碍的原因。关于治疗CSM的最佳手术入路，存在显著的实践差异和不确定性。主要目的是确定腹侧手术治疗CSM与背侧（椎板切除术/融合术或椎板成形术）手术治疗CSM相比，1年随访时是否与上级SF-36身体健康总评（PCS）结局相关。该研究还将调查术后矢状面平衡是否是总体结局的独立预测因素，并将比较腹侧和背侧手术的卫生资源利用。该研究是一项随机对照试验，其中有一个非随机化组，适用于符合条件但拒绝随机化的患者。将在18个月内从11个研究中心招募250例CSM患者（159例随机化）。主要结局是简表-36 PCS评分。次要结局包括疾病特异性结局、总体健康相关生活质量（EuroQol-5D）和卫生资源利用。这将是第一个直接比较腹侧与背侧手术治疗CSM的健康相关生活质量结局的随机对照试验。在启动试验前，举行了由NIH资助的（1 R13 AR 065834 -01）研究者会议，以召集多个利益相关者共同完成研究方案。研究者、协调员和主要利益相关者能够参加并讨论本研究的优势、局限性和问题。最终方案已获得PCARI（CE-1304-6173）的资助。RCT于2014年4月1日开始入组。
Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There is significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. The primary objective is to determine if ventral surgery is associated with superior SF-36 Physical Component Summary (PCS) outcome at one year follow-up compared to dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM. The study will also investigate whether post-operative sagittal balance is an independent predictor of overall outcome and will compare health resource utilization for ventral and dorsal procedures. The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 PCS score. Secondary outcomes include disease specific outcomes, overall health-related quality of life (EuroQol-5D), and health resource utilization. This will be the first randomized controlled trial to compare directly the health-related quality of life outcomes for ventral versus dorsal surgery for treating CSM. An NIH-funded (1R13AR065834-01) investigator meeting was held prior to initiating the trial in order to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths, limitations, and concerns regarding the study. The final protocol was approved for funding by PCORI (CE-1304-6173). The RCT began enrollment on April 1, 2014.