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
- 60
- 试验地点
- 1
- 主要终点
- Lateral AP Translations, in mm
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.
详细描述
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. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.
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, either the BCS or XR, 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
Lateral AP Translations, in mm
时间窗: At least 6 months postoperative
Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Medial AP Translations, in mm
时间窗: At least 6 months postoperative
Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.
Maximum Flexion, in Degrees
时间窗: At least 6 months postoperative
Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.
Axial Rotation, in Degrees
时间窗: At least 6 months postoperative
Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.
次要结局
未报告次要终点