NCT05762588进行中（未招募）不适用
JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study
Riverpoint Medical1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Success
研究概览
简要总结
The purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the JuggerKnot device and meet existing EU regulatory requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the JuggerKnot with BroadBand anchor is indicated;
- •Male or non-pregnant female ≥ 18 years of age;
- •Willing to provide informed consent and comply with the required follow-up period.
排除标准
- •Infection where implantation of the device would be compromised;
- •Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue;
- •Known allergy to one of the JuggerKnot with BroadBand components;
- •Mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so.
结局指标
主要结局
Clinical Success
时间窗: 6 months
Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out.
次要结局
- VAS Pain Score(Change from baseline to 6 months)
- PROMIS Physical Function Score(Change from baseline to 6 months)
- Change in degrees of Range of Motion (ROM) measured by Goniometer(Change from baseline to 6 months)
- Technical and Procedural Success(Intraoperatively)
研究者
研究点 (1)
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