Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
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 pilot study will analyze 5 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. Since this is a pilot study, there is no hypothesis.
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
- •Must be willing to sign the Informed Consent (IC) and HIPAA forms to participate in the study
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: Translation and Lift-off for Ramp Down
时间窗: 3 months post-operative
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
Femoro-tibial Kinematics - Gait
时间窗: 3 months post-operative
Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend
时间窗: 3 months post-operative
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Femoro-tibial Kinematics: Translation and Lift-off for Gait
时间窗: 3 months post-operative
Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.
Femoro-tibial Kinematics - Deep Knee Bend
时间窗: 3 months post-operative
Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.
Femoro-tibial Kinematics - Ramp Down
时间窗: 3 months post-operative
Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.
次要结局
- Max Ground Reaction Force - Deep Knee Bend(3 months post-operative)
- Max Ground Reaction Force - Ramp Down(3 months post-operative)
- Max Ground Reaction Force - Gait(3 months post-operative)
研究者
Richard Komistek
Principal Investigator
The University of Tennessee, Knoxville