In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Kinematics - Ramp up Activity
研究概览
简要总结
This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.
详细描述
A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months
- •Must have body weight of less than 250 lbs
- •Must have Body Mass Index of less than 38
- •Must be judged clinically successful with a Knee Society Score >90
- •Must have 100% post-operative passive flexion with no ligamentous laxity or pain
- •Must be able to walk on level ground without aid of any kind
- •Must be able to ascend and descend a ramp with a 10 degree incline with no assistance
- •Must be willing to sign both Informed Consent and HIPAA forms
- •Must be between 160 cm (5'3) and 193 cm (6'4) tall
排除标准
- •Pregnant or potentially pregnant females
- •Unwilling to sign Informed Consent or HIPAA forms
结局指标
主要结局
Kinematics - Ramp up Activity
时间窗: 3 months post-operative
Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp up activity
Kinematics - Deep Knee Bend Activity
时间窗: 3 months post-operative
Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity
Kinematics - Ramp Down Activity
时间窗: 3 months post-operative
Lateral Anterior Posterior (LAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] and Medial Anterior Posterior (MAP) \[during 3 moments - 0-33%, 33-66% and 66-100%\] translations, and Axial Rotation (AR) \[during 3 moments - 0-33%, 33-66% and 66-100%\] of medial femoral condyles during ramp down activity
次要结局
未报告次要终点
研究者
Richard Komistek
Principal Investigator
The University of Tennessee, Knoxville