Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Patient reported outcome measures
研究概览
简要总结
The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage osteoarthritis of the knee joint with failed conservative treatment
排除标准
- •Previous ligament trauma
- •Previous fracture of femur or tibia
- •Fixed flexion contracture > 10°
- •Flexion < 110°
- •Coronal deformity > 15°
- •Previous infection of the knee joint
- •Ligament insufficiency
- •Neurologic conditions
研究组 & 干预措施
Posterior Stabilized with robot-assistance
A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance
干预措施: Total Knee Prosthesis - type Posterior Stabilized (Procedure)
Posterior Stabilized TKA without robot-assistance
A TKA procedure will carried out: Posterior Stabilized TKA without robot-assistance
干预措施: Total Knee Prosthesis - type Posterior Stabilized (Procedure)
Posterior Stabilized with robot-assistance
A TKA procedure will carried out: Posterior Stabilized TKA with robot-assistance
干预措施: Robot-assisted Total Knee Arthroplasty (Procedure)
Bicruciate retaining TKA without robot-assistance
A TKA procedure will carried out: Bicruciate retaining TKA without robot-assistance
干预措施: Total Knee Prosthesis - type Bicruciate retaining (Procedure)
Bicruciate retaining TKA with robot-assistance
A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance
干预措施: Total Knee Prosthesis - type Bicruciate retaining (Procedure)
Bicruciate retaining TKA with robot-assistance
A TKA procedure will carried out: Bicruciate retaining TKA with robot-assistance
干预措施: Robot-assisted Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Patient reported outcome measures
时间窗: Preoperative
The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change in patient reported outcome measures
时间窗: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
次要结局
- Knee laxity(Preoperative and postoperatively at 1 year.)
- Alignment(Preoperative and postoperatively at 6 weeks and 6 months.)
- Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.(Postoperatively at 1 year.)