Three-year results of the MOTION randomized controlled trial for treatment of lumbar spinal stenosis using the percutaneous mild® Procedure

Shrif J. Costandi , Timothy R. Deer , Timothy B. Chafin , Christopher Kim
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Abstract

Objective

The MOTION prospective, multicenter randomized controlled trial compares the outcomes of percutaneous image-guided lumbar decompression in combination with conventional medical management (CMM) to the use of CMM alone for the treatment of lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. The study includes extended follow-up for patients in both the treatment group and for those who crossed over from the control group to the treatment group.

Methods

The treatment group received the mild® Procedure (Vertos Medical, Aliso Viejo, CA, USA) in combination with nonsurgical CMM, while the active control group received CMM alone. There were no restrictions for either group regarding access to real-world CMM therapies. Patients reported outcomes using the Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and Numeric Pain Rating Scale (NPRS). Objective outcomes were measured using a validated Walking Tolerance Test (WTT), the incidence of subsequent lumbar spine interventions, and the occurrence of adverse events.

Results

Forty-eight patients initially receiving mild + CMM consented to extended follow-up and were available for 3-year follow-up. All outcomes for this group were significantly improved over baseline (p-values ranging from <0.0001 to 0.0001). At 3-year, ODI, NPRS back and leg, ZCQ symptom severity, and physical function improved by 16.9, 3.0, 4.3, 0.8, and 0.6, respectively. Walking tolerance test demonstrated 274 % improvement from baseline, and only 4 (5.6 %) patients had received surgical intervention. No device- or procedure-related adverse events were reported.

Conclusions

MOTION 3-year follow-up results continue to demonstrate the safety and durability of the mild Procedure combined with CMM for early interventional treatment of symptomatic LSS. The absence of device or procedure-related adverse events further underscores the robust safety profile of the mild Procedure. Significant and substantial improvements in all the outcomes were observed from baseline to follow-up for patients treated with the mild Procedure. These results support the mild Procedure as an effective approach for early intervention in LSS treatment.
使用经皮mild®手术治疗腰椎管狭窄的MOTION随机对照试验的三年结果
目的:MOTION前瞻性、多中心随机对照试验比较经皮影像引导下腰椎减压联合常规医疗管理(CMM)与单独使用CMM治疗腰椎管狭窄伴黄韧带肥厚性继发性神经源性跛行的疗效。这项研究包括对治疗组和从对照组转到治疗组的患者进行长期随访。方法治疗组采用轻度®手术(Vertos Medical, Aliso Viejo, CA, USA)联合非手术性CMM,而积极对照组单独采用CMM。两组在获得真实CMM治疗方面都没有限制。患者使用Oswestry残疾指数(ODI)、苏黎世跛行问卷(ZCQ)和数字疼痛评定量表(NPRS)报告结果。客观结果通过有效的行走耐量试验(WTT)、随后腰椎干预的发生率和不良事件的发生来衡量。结果48例初始接受轻度+ CMM治疗的患者同意延长随访,随访时间为3年。该组的所有结局均较基线显著改善(p值范围为<;0.0001至0.0001)。3年时,ODI、NPRS背部和腿部、ZCQ症状严重程度和身体功能分别改善16.9、3.0、4.3、0.8和0.6。行走耐量试验显示较基线改善274%,只有4例(5.6%)患者接受了手术干预。没有器械或手术相关的不良事件报告。结论:3年随访结果继续证明轻度手术联合CMM早期介入治疗症状性LSS的安全性和持久性。没有器械或手术相关的不良事件进一步强调了温和手术的强大安全性。从基线到随访,轻度手术治疗的所有结果均有显著改善。这些结果支持轻度手术作为LSS治疗早期干预的有效方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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