NCT03633201进行中（未招募）不适用
Anatomic Congruent Prosthetic Knee Design - a Kinematic and Kinetic Comparison With a Standard Prosthetic Knee Design and the Native Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Kinematics - knee joint movement
研究概览
简要总结
This double-blinded randomized control study will use kinematic and kinetic measures to compare an anatomical congruent prosthetic knee design to a standard prosthetic knee design. The patients will be measured pre- and post-operative and compared to a healthy non-osteoarthritis control group.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed and written consent.
- •Primary knee osteoarthritis in capable men and women.
- •Indication for cruciate-retaining total knee arthroplasty.
排除标准
- •Patients who do not speak and read Danish.
- •Patients who are pregnant or at risk of becoming pregnant during the project.
- •Patients with active cancer and/or radiation or chemotherapy.
- •Patients who are alcoholics or have some form of abuse that impede information and follow-up.
- •Patients with severe psychiatric disease that might complicate compliance with follow-up.
- •Patients with surgically implants in the affected leg and/or pace maker.
- •Patients with greater thigh circumference then 60 cm.
- •Patients cannot perform the described exercises.
- •Patients with knee instability due to multiligament injury.
- •Patients with conditions that severely compromise their gait other than knee osteoarthritis in the affected knee.
- •Patients with severe fracture sequelae or severe malalignment at knee level.
- •Patients with osteosynthesised fractures using bone graft at knee level.
- •Patients with need of an augmentation and/or stem-elongation.
- •Patients with metabolic bone disease.
- •Patients with rheumatoid arthritis.
结局指标
主要结局
Kinematics - knee joint movement
时间窗: 1 year follow-up
Relative movement (position in millimetres and orientation in degrees) of the knee joint.
次要结局
- Static implant migration(3, 12 and 24 month post operation using first operative day as baseline.)
- Articular joint contact(1 year follow-up)
- Implant inducible micromotion(1 year follow-up)
- Kinetic - knee joint contact force(1 year follow-up)
- Patient Reported Output Measure(1 year follow-up)
研究者
研究点 (2)
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