临床试验/NCT02425631

NCT02425631已完成不适用

CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

Zyga Technology, Inc.0 个研究点目标入组 19 人开始时间: 2014年10月最近更新: 2016年9月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Zyga Technology, Inc.
入组人数: 19
主要终点: SI Joint Fusion (CT evidence of SI joint fusion)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patient must have a SImmetry device implanted.
•Patient is willing to comply with study procedures and provide informed consent.

排除标准

•Patient is physically unable to return to the clinic for CT imaging.

结局指标

主要结局

SI Joint Fusion (CT evidence of SI joint fusion)

时间窗: 12 months

CT evidence of SI joint fusion evaluated by a core laboratory

次要结局

SI Joint Pain (CT evidence of SI joint fusion)(24 months)

研究者

发起方

Zyga Technology, Inc.

申办方类型

Industry

责任方

Sponsor

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