In Vivo Kinematic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design During Activities of Daily Living
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion
研究概览
简要总结
The aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of femoral rollback will be analyzed to assess if they are motor-task dependent and correlated with clinical 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
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients submitted to Total knee arthroplasty (TKA) with Physica KR or PS;
- •Patients with an appropriate initial fixation and stability of the knee prosthesis;
- •Patients achieving a minimum flexion of 100° or a Knee Society Score (KSS) ≥ 65 (fair/good postoperative outcome) at 6-month follow-up;
- •Patients affected by primary or secondary Osteoarthritis (OA) before surgery;
- •Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
- •Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.
排除标准
- •Patients with misalignment or axial malrotation of the knee prosthesis;
- •Patients not able to achieve a minimum flexion of 100° or with a KSS Knee Score ≤ 65 points at 6-month follow-up;
- •Patients who had or have planned a surgery on their uninvolved knee within a year;
- •Muscular insufficiency or absence of muscololigamentous supporting structures required for adequate soft tissue balance;
- •Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
- •Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study;
- •Participation in any experimental drug/device study within the 6 months prior to the screening visit
- •Female patients who are pregnant, nursing, or planning a pregnancy due to x-rays exposition.
结局指标
主要结局
Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion
时间窗: 6 months
Using a software to replicate the movement using Computer-aided design (CAD) models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back.
次要结局
未报告次要终点