Kinematics Analysis: Comparison Between the Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty ATTUNE TM Knee System and the Fixed Bearing PFC Sigma Curved Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA
研究概览
简要总结
The primary objective is to quantify and compare the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.
The secondary objective is to describe the kinematics in terms of range of motion, patterns of anterior-posterior motion of the nearest medial and lateral points ("posterior femoral rollback") and tibio-femoral internal/external rotation as well as the kinetics during daily activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent by means of video-fluoroscopy.
Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and to the Center for Orthopaedic Engineering of the University of Denver, where it will be used within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and changes in the musculoskeletal system due to the TKA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
- •Good clinical outcome, KOOS > 70
- •No or very low pain VAS < 2
- •At least one year post-op
- •Standardized general health survey score (SF-12) within the normal range for people in their age group
排除标准
- •Actual significant problem on lower extremities
- •Misaligned TKA
- •Any other arthroplasty at the lower extremities
- •Patient incapable to understand and sign informed consent
- •Incapable of performing the motion tasks
- •Pregnancy
结局指标
主要结局
Comparison of the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA
时间窗: 3 hours
With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the ATTUNETM System during daily activities and allows a comparison to a conventional TKA based on the same methodology. The knowledge of the in vivo kinematic behaviour of the ATTUNETM System in comparison to the conventional TKA leads to an improved understanding of the design principle.
次要结局
未报告次要终点
研究者
Dr. Renate List
Dr. sc. ETH, Group Leader Clinical Movement Biomechanics, Senior Research Associate
Institute for Biomechanics, ETH Zürich