Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Height
研究概览
简要总结
General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes.
详细描述
First specific aim: to investigate the kinematics during daily functional movements in individuals with the iKA TKA to those with aMA TKA, as well as the healthy control group.
Second specific aim: to investigate kinetics and muscle activation patterns during functional movements in individuals with the iKA aligned TKA to those with aMA TKA, as well as a healthy control group.
Third specific aim: to investigate the impact of the whole body on functional outcomes following iKA and aMA TKA, in comparison to the healthy control group, and to explore the underlying factors contributing to suboptimal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •were age under 85 years. primary robot-assisted TKA using either iKA or aMA. surgery performed two years before enrollment. independent ambulation without assistive devices; and informed consent.
排除标准
- •history of lower limb trauma or fracture. neurological disorders (e.g., stroke, Parkinson's disease, multiple sclerosis). systemic musculoskeletal diseases (e.g., rheumatoid arthritis, diabetic neuropathy).
- •revision arthroplasty. and cognitive impairment affecting study participation.
研究组 & 干预措施
To examine the lower limb kinematic differences during the challenging daily functional movements, s
To examine the lower limb kinematic differences during the challenging daily functional movements, such as the lunge, in individuals who have undergone iKA TKA, compared to those with aMA TKA and healthy controls.
干预措施: iKA (Procedure)
结局指标
主要结局
Height
时间窗: 2 years after TKA
Stadiometer; height in millimeters
Joint angles
时间窗: 2 years after surgery
Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees
Age
时间窗: 2 years after TKA
year
Leg Length
时间窗: 2 years after TKA
Direct Tape Measure; Leg Length in millimeters
Inter-ASIS Dist
时间窗: 2 years after TKA
Vernier caliper， Inter-ASIS Dist in millimeters
Knee Width
时间窗: 2 years after TKA
Vernier caliper, Knee Width in millimeters
Ankle Width
时间窗: 2 years after TKA
Vernier caliper, Ankle Width in millimeters
Elbow Width
时间窗: 2 years after TKA
Vernier caliper, Elbow Width in millimeters
Wrist Width
时间窗: 2 years after TKA
Vernier caliper, Wrist Width in millimeters
Hand Thickness
时间窗: 2 years after TKA
Vernier caliper, Hand Thickness in millimeters
Total Gait Cycle Duration
时间窗: 2 years after TKA
Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second
Visual Analog Scale
时间窗: Pre-TKA, 6 weeks after TKA, 2 years after TKA
Pain Scores
Oxford Knee Score (OKS)
时间窗: Pre-TKA; 2 years after TKA
total score ranging from 0 to 48
maximum voluntary isometric strength tests of the lower limb
时间窗: 2 years after TKA
Peak force measured with a hand-held dynamometer (Micro FET 2 Handheld Dynamometer, Hoggan, USA); Unit: Newtons
Muscle activity patterns for eight muscles (gluteus medius, rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior and gastrocnemius medialis)
时间窗: 2 years after TKA
A 16-channel telemetric wireless surface electromyography (EMG) system (Waveplus®, Cometa, Rome, Italy) operating at 1000 Hz was utilized. Unit: Volt
次要结局
- BMI(2 years after TKA)