Multi-center In Vivo Kinematics for Subjects Implanted With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Femorotibial Axial Rotation
研究概览
简要总结
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the age range of 18 years to 85 years (both inclusive)
- •Patients who have a BMI less than 35
- •Patients who do not have previous surgery on the implanted knee that might restrict their movement
- •Patient who are at least 6 months post-operative
- •Patients who do not experience any pain or other post-operative complications
- •Patients who have a stable TKA and can perform a deep knee bend activity
- •Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
- •Subjects will have a Journey II knee system
排除标准
- •Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
- •Patients who have currently enrolled in a fluoroscopic study within the past year.
- •Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
- •Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
- •Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
- •Subjects who are unable to perform a deep knee bend.
- •Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- •Subjects without the required type of knee implant.
结局指标
主要结局
Femorotibial Axial Rotation
时间窗: Baseline, at time of observation
The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[deg\].
Femorotibial Weight Bearing Flexion
时间窗: Baseline, at time of observation
The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[deg\].
Femorotibial Medial Condylar Rollback
时间窗: Baseline, at time of observation
The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].
Femorotibial Lateral Condylar Rollback
时间窗: Baseline, at time of observation
The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].
次要结局
未报告次要终点