NCT04681404招募中不适用
Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
Johannes Kepler University of Linz2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Center of pressure track (COPT)
研究概览
简要总结
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary gonarthrosis
- •planned TKA or UKA
- •adequate cognitive and lingual competence
- •informed consent
排除标准
- •TKA or UKA revision
- •Surgery after trauma
- •Rheumatic disease
- •Neurologic disease
- •previous arthroplasty of the lower extremity (<9 months)
- •cardiovascular disease
- •restricted weight bearing of the lower extremity after surgery
结局指标
主要结局
Center of pressure track (COPT)
时间窗: 1 year after surgery
Posturographic Parameter
次要结局
- Oxford Knee Score(Before surgery; 1 year after surgery)
- Frequency of Sway(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- WOMAC Score(Before surgery; 1 year after surgery, higher score means better outcome)
- Functional reach test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Timed up and go - test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Forgotten Joint Score(Before surgery; 1 year after surgery)
- Knee Injury and Osteoarthritis Outcome Score(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- EQ-5D - Score(Before surgery; 1 year after surgery)
- 10 m Walking test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Knee Society Score(Before surgery; 1 year after surgery)
- The University of California at Los Angeles Activity Score(Before surgery; 1 year after surgery)
- Area of Sway(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Harmony Index(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Stability energy(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Movement control(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Feedback (visual, somatosensoric, vestibular)(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Weight Distribution Index(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Fulfillment of Tests(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
研究者
Christian Mittermaier
Christian Mittermaier, MD
Johannes Kepler University of Linz
研究点 (2)
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