Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiographic outcomes : Hip-knee-ankle angle
研究概览
简要总结
Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.
Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80 years
- •Symptomatic bilateral knee Osteoarthritis requiring primary TKA
- •Willing to undergo bilateral simultaneous TKA
- •Able to give informed consent
排除标准
- •ligament deficiency requiring constrained prosthesis
- •bone loss with augmentation need
- •history of fracture around knee or previous osteotomy
- •history of ankle fracture
- •patient with neuromuscular disorder or movement disorder
- •patient is unable to attend the study follow-up program
研究组 & 干预措施
Functional alignment
干预措施: Functional alignment (Other)
Mechanical alignment
干预措施: Mechanical alignment (Other)
结局指标
主要结局
Radiographic outcomes : Hip-knee-ankle angle
时间窗: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond
Radiographic outcomes :Talar inclination
时间窗: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between talar dome and vertical axis
Radiographic outcomes : Tibial plafond inclination
时间窗: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between subchondral plate of distal tibial articular surface and vertical axis
Radiographic outcomes : Tibiotalar tilt angle
时间窗: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between subchondral plate of distal tibial articular surface and talar dome
次要结局
- Quality of Life score : EQ-5D-5L(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)
- Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)
- Forgotten Joint Score(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)
- Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score(pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks)