Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion
研究概览
简要总结
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Specifically, posterior stabilizing (PS) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. To understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least three (3) months post-operative with no other surgical procedures conducted within the past six months
- •Between 30-80 years of age
- •Body weight of less than 280 lbs
- •Must be between 160cm (5'3) and 193cm (6'4) tall
- •Body Mass Index (BMI) >18.5 and <35
- •Judged clinically successful with a Knee Society score (KSS) of greater than 80
- •Have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain
- •Must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (DKB), all without assistance
- •Will have a DePuy Attune PS TKA
排除标准
- •Pregnant or potentially pregnant females will be excluded from the study.
结局指标
主要结局
Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion
时间窗: 3 months post-operative
Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down
Femoro-tibial Kinematics - Medial Anterior/Posterior Motion
时间窗: 3 months post-operative
Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down
Femoro-tibial Kinematics - Axial Rotation
时间窗: 3 months post-operative
Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.
Femoro-tibial Kinematics - Weight-bearing Flexion
时间窗: 3 months post-operative
Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.
次要结局
- Max Ground Reaction Force - Ramp Down(3 months post-operative)
- Max Ground Reaction Force - Deep Knee Bend(3 months post-operative)
- Max Ground Reaction Force - Gait(3 months post-operative)
研究者
Richard Komistek
Fred M. Roddy Professor of Biomedical Engineering
The University of Tennessee, Knoxville