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临床试验/NCT03074916
NCT03074916已完成不适用

Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint

Schulthess Klinik1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年3月8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
52
试验地点
1
主要终点
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up

研究概览

简要总结

The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.

The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 111 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arthroplasty group:
  • DIP silicone arthroplasty at least one year ago
  • Informed consent as documented by signature
  • Arthrodesis group:
  • Matched patients with an DIP arthrodesis
  • Informed consent as documented by signature

排除标准

  • Arthroplasty group:
  • Silicone arthroplasty at the thumb IP joint
  • Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
  • Legal incompetence
  • German language barrier to complete the questionnaires
  • Arthrodesis group:
  • Arthroplasty at another DIP joint
  • Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
  • Legal incompetence
  • German language barrier to complete the questionnaires

结局指标

主要结局

satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up

时间窗: at least 1 year up to 7 years

Question to be answered on a 5 Point Likert scale

次要结局

  • Michigan Hand Questionnaire(at least 1 year up to 7 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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