NCT06487936招募中不适用
A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
CornerLoc1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient Satisfaction Survey
研究概览
简要总结
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 year or older
- •Confirmed Implant of the Transloc 3D Fusion System
- •Did not have Transloc device removed or another manufacturer device implanted post Transloc
- •Does not have other manufacturer's titanium or metal implant
- •Patient may be included with prior allograft implant
- •Willing to participate and give written consent
- •Must have or planned CT post ≥1 year per standard of care
排除标准
- •Patient is younger than 18 years
- •Patient is unable to sign the Informed Consent
- •Implant of other manufacturer's titanium or alternative metal implant
- •Revision with another manufacturer's implant
- •Fracture or unresolved trauma of implant side after implantation of TransLoc
- •Patient unwilling to participate in Patient Satisfaction Survey
- •Patient has not returned for Standard of Care follow-up
结局指标
主要结局
Patient Satisfaction Survey
时间窗: Prospective 12 to 18 months post surgery
Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint
次要结局
- Visual Analogue Scale (VAS) of pain(Baseline up to 1 year post surgery)
- Oswestry Disability Index (ODI)(Baseline up to 1 year post surgery)
- CT Scan Second Read (Radiological Overread)(12 to 18 months post fusion surgery)
- SAEs(Time of surgery up to 90 days post surgery)
研究者
研究点 (1)
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