NCT06546332进行中（未招募）不适用
Effectiveness and Safety of the KeriFuse® Intramedullary Arthrodesis Implant and Associated Instruments in the Treatment of IP or DIP Arthritis: a Post Market Clinical Follow-up.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 97
- 试验地点
- 8
- 主要终点
- Pain and radiological assessment
研究概览
简要总结
The general objective of this study is to evaluate the performances and the safety related to the KeriFuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. Performance and safety of KeriFuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients ≥ 18 years,
- •Patients that will have a surgery using a KeriFuse® implant in accordance with the approved labelling and IFU.
排除标准
- •Pregnant or nursing women,
- •Patients with intellectual disabilities who cannot follow the instructions of their surgeon,
- •Patients with a contraindication to surgery and more specifically to the implantation of KeriFuse®,
- •Patients with acute or chronic infections, local or systemic,
- •Patients with sensitivities or allergies to the implant components (Nickel, Titanium).
结局指标
主要结局
Pain and radiological assessment
时间窗: 3 months
At 3 months postoperatively, the proportion of patients with a pain level ≤ 3 on VAS (ranking from 0 to 10 cm) and with a fused DIP or IP joint (radiological assessment)
次要结局
未报告次要终点
研究者
研究点 (8)
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