Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Performance Testing - step-up step-down speed - faster is better
研究概览
简要总结
Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained prior to any screening procedures
- •Received a primary total knee replacement (incl. patella) robotically-assisted
- •Male or female
- •Age between 50 and 80
- •Able to walk independently
排除标准
- •Revision surgery
- •Patient with a history of neurological, psychiatric or neurodegenerative disease
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Other musculoskeletal lesions that may affect the gait pattern
结局指标
主要结局
Performance Testing - step-up step-down speed - faster is better
时间窗: 2 year
Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity
Gait Analysis - walking speed - faster is better
时间窗: 2 year
Spatio Temporal Parameters are captured with infra-red camera during gait: velocity
次要结局
- Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48(baseline - 1 year - 2 year)
研究者
Philip Winnock de Grave, MD
Principal Investigator
AZ Delta