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临床试验/NCT06061367
NCT06061367招募中不适用

Influence of Lower Extremity Muscles Strength on Physical Function, Biomechanical Gait Parameters and Reported Outcome After Total Knee Arthroplasty

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月30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
100
试验地点
1
主要终点
Gait biomechanics analysis - step length

研究概览

简要总结

Total Knee Arthroplasty (TKA) is actually the most effective treatment option for patients with end-stage osteoarthritis (OA). However, nearly 20% of patients who underwent TKA remain unsatisfied with their clinical outcome. Investigating modifiable factors that limit knee functioning following TKA we may notice the significance of lower limb muscles strength. Gait pattern is also affected by OA, as arthritic knee joint cannot provide proper range of motion (ROM) and stability.Therefore any deviation in biomechanics should be noticed and analyzed. After TKA patients' physical function may change, but the study should be conducted to prove whether it improves or not. Patient-reported outcome defined by OKS (Oxford Knee Score) and FJS (Forgotten Joint Score) questionnaires will be evaluated.

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

  • III° or IV° grade knee osteoarthritis
  • Age over 50
  • Patients with signed consent

排除标准

  • Undergone total hip replacement
  • Previous femur fracture in anamnesis
  • Undergone corrective osteotomy
  • Active/ Chronic neoplastic disease
  • Significant deformation of lower limb axis
  • Mental disorders
  • Muscular disorders

结局指标

主要结局

Gait biomechanics analysis - step length

时间窗: 6 months

Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the step length (in meters).

Muscle strength measurement with a use of dynamometer

时间窗: 6 months

Analysis of pre- and postoperative strength of lower limb muscles. Assessment of force \[N\] generated by knee flexors, knee extensors, hip adductors and hip abductors with a use of a hand-held dynamometer.

Gait biomechanics analysis - gait speed

时间窗: 6 months

Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the gait speed (metre per second).

Gait biomechanics analysis - phases of gait

时间窗: 6 months

Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the swing and the stance phase of gait (% of the gait cycle).

Gait biomechanics analysis - step duration

时间窗: 6 months

Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the duration of left and right step (in seconds).

Physical function assessment based on standardized test

时间窗: 6 months

Analysis of pre- and postoperative physical function on the basis of Up and Go test.

次要结局

  • Patient-reported outcome - Oxford Knee Score(6 months)
  • Patient-reported outcome - Forgotten Joint Score(6 months)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Artur Stolarczyk

Professor

Medical University of Warsaw

研究点 (1)

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