NCT02425319已完成不适用
Motion Analysis of the Proximal Interphalangeal Joint in Healthy Hands, as Well as in Osteoarthritis Hands Following Implantation With the New CapFlex-PIP© Implant Compared With Silicone Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lateral stability in coronal plane (to ulnar and radial side) during motion analysis
研究概览
简要总结
The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.
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
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or
- •Patient with one untreated healthy hand without joint osteoarthritis
- •Patient aged 50 years and over
- •Patient willing and able to give written informed consent to participate in the study
排除标准
- •Inflammatory disease (e.g. rheumatoid arthritis)
- •Pregnant women
- •German language barrier to complete the questionnaires
- •Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- •Legal incompetence
- •Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
结局指标
主要结局
Lateral stability in coronal plane (to ulnar and radial side) during motion analysis
时间窗: 1-5 years postoperative
Active PIP joint range of motion (flexion and extension lag) during motion analysis
时间窗: 1-5 years postoperative
次要结局
未报告次要终点
研究者
Stephan Schindele
Dr. med.
Schulthess Klinik
研究点 (1)
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