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临床试验/NCT01871272
NCT01871272已完成不适用

Knee Arthroscopy Cohort Southern Denmark (KACS)

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
491
试验地点
2
主要终点
Knee Injury and Osteoarthritis Outcome Score (KOOS)

研究概览

简要总结

PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.

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

入选标准

  • Assigned for arthroscopy on suspicion of a medial and/or lateral meniscus tear.
  • Age >18 years at time of recruitment
  • Having an email address
  • Able to read and understand Danish

排除标准

  • Patients who will or have previously undergone surgical reconstruction of the anterior or posterior cruciate ligament (ACL or PCL) in either knee
  • Fracture to the lower extremities (i.e. hip, leg or foot) in either leg within the last 6 months prior to recruitment
  • Not mentally able to reply to the questionnaire

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up

Knee specific questionnaire. All domains on the KOOS. Primary end point is change from PRE surgery (assessed 1-14 days prior to surgery) to 52 weeks follow-up.

次要结局

  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)(PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up.)
  • Patient Acceptable Symptom State (PASS)(At 12 weeks and 52 weeks follow-up.)
  • Treatment failure (TF)(At 12 weeks and 52 weeks follow-up.)

研究者

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

Jonas Bloch Thorlund

Associate Professor

University of Southern Denmark

研究点 (2)

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Knee Arthroscopy Cohort Southern Denmark (KACS) | 临床试验