跳至主要内容
临床试验/NCT02175160
NCT02175160已完成不适用

Predictability of the Ability to Perform an Emergency Stop in Knee Osteoarthritis and Patients With Total Knee Arthroplasty

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年7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
60
试验地点
2
主要终点
Correlation of knee functionality and braking performance

研究概览

简要总结

Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • valid driving license
  • male and female
  • right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
  • capability to walk with or without a walking stick

排除标准

  • myocardial infarction/Apoplexia < 6 months
  • Total knee arthroplasty <5 weeks
  • New York Heart Association 3/4
  • lacking drivers' license
  • peripheric sensomotor deficit <3/5 British Medical Research Council
  • new fracture of the lower extremity or spine
  • systemic or metastasised Cancer
  • drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)

结局指标

主要结局

Correlation of knee functionality and braking performance

时间窗: Osteoarthritis group: at consultation, Total knee arthroplasty group: more than 5 weeks postoperatively, at consultation

Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of knee functionality in patients with right knee osteoarthritis or total knee arthroplasty. One time point of evaluation for each participant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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