跳至主要内容
临床试验/NCT02425319
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

Schulthess Klinik1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月14日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Schindele

Dr. med.

Schulthess Klinik

研究点 (1)

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