NCT06546345招募中不适用
Effectiveness and Safety of the Silicone Joint Implant KeriFlex® and of Its Associated Instruments in the Treatment of MCP and PIP Arthritis: Post Market Clinical Follow up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 3
- 主要终点
- Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand
研究概览
简要总结
The general objective of this study is to assess the performance and safety of the KeriFlex® silicone joint implant and its associated instruments, used in accordance with the labeling and instructions in force.
The performance and safety of the KeriFlex® joint implant will be established in the short and long term with regard to the life cycle of the implant.
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
- •Adult patients (age ≥ 18 years)
- •Patients who are going to undergo arthroplasty of the metacarpophalangeal or proximal interphalangeal joint using a KeriFlex® implant in accordance with the instructions for use and the labelling in force.
- •Patients with rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis
排除标准
- •Pregnant or breastfeeding women
- •Patients with an intellectual disability who cannot follow their surgeon's instructions
- •Patients with general surgery contraindications and particularly to the implantation of a KeriFlex® implant
- •Patients with acute or chronic, local or systemic infections
- •Metacarpal or phalanx destruction or poor bone quality preventing adequate fixation
- •Muscle loss, alteration or vascular deficiency in the affected finger
- •Patients with significant physical activity involving treated joint
- •Children, young growing patients with open epiphyses
结局指标
主要结局
Assessment of the effectiveness of the KeriFlex® implant in improving the functional results of the hand
时间窗: 6 months
Proportion of patients with a bMHQ score greater than the preoperative value at 6 months (postoperative).
次要结局
未报告次要终点
研究者
研究点 (3)
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