In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune Posterior Cruciate Retainign Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Kinematics during step up activity
研究概览
简要总结
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with either a MicroPort Medial Pivot or DePuy Attune posterior cruciate retaining (PCR) total knee arthroplasty (TKA) by Dr. Russell Nevins of Nevada Orthopedic & Spine Center [this is the location from which participants will be recruited].
详细描述
There will be ten subjects with the MicroPort implant and ten with the DePuy Attune implant; however, we will increase enrollment to 24 subjects (12 in each group) to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. All TKAs should be judged clinically successful based on the surgeon's evaluation and each patient's Forgotten Knee Score. Each subject should have a well-functioning prosthesis, be at least six months post-operative, and should have good-to-excellent post-operative passive flexion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will have either a MicroPort Medial Pivot or DePuy Attune PCR TKA.
- •Subjects must be at least six months post-operative.
- •Participants must be judged clinically successful based on the surgeon's evaluation and their Forgotten Knee Score.
- •Participants must be able to perform the required activities - stepping up and a deep knee bend.
- •Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study
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.
- •Subjects without one of the two types of knee implants under investigation.
- •Subjects who are unable to perform stepping up and deep knee bend.
- •Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- •Does not speak English.
结局指标
主要结局
Kinematics during step up activity
时间窗: at least 6 months post-operative
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during step up activity
Kinematics Translations during Deep Knee Bend Activity
时间窗: at least 6 months post-operative
Anterior Posterior (AP) translations of lateralfemoral condyles during deep knee bend
Kinematics during Deep Knee Bend Activity
时间窗: at least 6 months post-operative
Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Kinematics Translations during step up activity
时间窗: at least 6 months post-operative
Anterior Posterior (AP) translations of lateralfemoral condyles during step up activity
次要结局
未报告次要终点
研究者
Richard Komistek
Fred M. Roddy Professor of Biomedical Engineering
The University of Tennessee, Knoxville