Hartjen Charles A, Resnick Daniel K, Hsu Ken Y, Zucherman James F, Hsu Emily H, Skidmore Grant A
*Greater Baltimore Spine Care, Towson, MD†Department of Neurological Surgery, University of Wisconsin School of Medicine, Madison, WI‡St Mary's Hospital, San Francisco§Medtronic Spine LLC, Sunnyvale, CA∥Neurosurgical Specialists Inc., Norfolk, VA.
Clin Spine Surg. 2016 Aug;29(7):305-11. doi: 10.1097/BSD.0b013e31827b671f.
Multicenter, prospective single-arm study in patients diagnosed with neurogenic intermittent claudication because of lumbar spinal stenosis.
To collect data from 2 different primary patient populations, new participants meeting entry criteria [Continued Access Program (CAP)], or subjects who had been randomly assigned to nonsurgical management in the pivotal Investigational Device Exemption study and failed to respond upon study completion [Crossover Study (COS)].
The X-STOP interspinous spacer is a minimally invasive treatment option for neurogenic intermittent claudication shown to improve pain, physical functioning, and/or overall quality of life.
Fifty-five subjects were enrolled, 42 in CAP and 13 in COS. Zurich Claudication Questionnaire (ZCQ) success rates were obtained based on the number of subjects achieving a threshold level of success. Mean SF-36 domain scores were compared with baseline using repeated measures analysis of variance.
Eighty percent of subjects completed the study. At 2 years, 26/43 subjects (60.5%) achieved clinically significant improvement in the Symptom Severity domain, 25/43 (58.1%) achieved clinically significant improvement in the Physical Function domain, and 31/44 (70.5%) achieved clinically significant improvement in the Patient Satisfaction domain of the ZCQ. Statistically significant improvement in mean scores was obtained in all physical domains of the SF-36 (with the exception of General Health) at 24 months. Mean improvement in ZCQ and SF-36 scores was not as pronounced in the COS cohort compared with the CAP cohort. The most frequently reported device-related or treatment-related adverse event was stenosis pain reported by 3 subjects.
Overall data are consistent with the randomized pivotal Investigational Device Exemption trial. On the basis of the COS cohort which was subject to several additional years of failed conservative treatment, overall success rates do not improve as greatly in patients with long-standing lumbar spinal stenosis symptoms.
针对因腰椎管狭窄症而被诊断为神经源性间歇性跛行的患者进行的多中心、前瞻性单臂研究。
从2个不同的主要患者群体中收集数据，即符合入选标准的新参与者[持续接入计划（CAP）]，或在关键的研究器械豁免研究中被随机分配至非手术治疗且在研究结束时无反应的受试者[交叉研究（COS）]。
X-STOP椎间间隔器是一种用于神经源性间歇性跛行的微创治疗选择，已证明可改善疼痛、身体功能和/或总体生活质量。
招募了55名受试者，其中42名纳入CAP，13名纳入COS。根据达到成功阈值水平的受试者数量获得苏黎世跛行问卷（ZCQ）成功率。使用重复测量方差分析将SF-36领域平均得分与基线进行比较。
80%的受试者完成了研究。在2年时，43名受试者中有26名（60.5%）在症状严重程度领域取得了临床上的显著改善，43名受试者中有25名（58.1%）在身体功能领域取得了临床上的显著改善，44名受试者中有31名（70.5%）在ZCQ的患者满意度领域取得了临床上的显著改善。在24个月时，SF-36的所有身体领域（除一般健康外）的平均得分均取得了统计学上的显著改善。与CAP队列相比，COS队列中ZCQ和SF-36得分的平均改善并不明显。最常报告的与器械相关或与治疗相关的不良事件是3名受试者报告的狭窄疼痛。
总体数据与随机关键研究器械豁免试验一致。基于经历了数年额外保守治疗失败的COS队列，长期腰椎管狭窄症状患者的总体成功率并未有太大提高。
