In Vivo Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Range of Motion During Flexion of Deep Knee Bend Activity
研究概览
简要总结
Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.
详细描述
Additional hypotheses:
- Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics.
- Subjects having a Sigma RP PS TKA will experience optimal cam/post mechanics.
- Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion.
- Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and cam/post contact forces over a broad area on the post.
- Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post, not an abrupt slide as seen with fixed bearing PS TKA.
- The use of the sound sensors will detect cam/post contact mechanics under in vivo conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least six months post-operative
- •Between 40-85 years of age
- •Have a body weight of less than 250 lbs.
- •Judged clinically successful with a AKS greater than 90
- •Have the DePuy Sigma mobile bearing TKA
- •Good-to-excellent post-operative passive flexion
- •Must be willing to sign the IC and HIPAA forms.
排除标准
- •Pregnant females
- •Those not willing to sign the IC and HIPAA forms
结局指标
主要结局
Range of Motion During Flexion of Deep Knee Bend Activity
时间窗: 10 yrs post-operative
In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity
时间窗: 10 yrs post-operative
The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.
Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity
时间窗: 10 yrs post-operative
次要结局
- In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity(10 yrs post-operative)
- Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity(10 yrs post-operative)
- Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity(10 yrs post-operative)
研究者
Richard Komistek
Principal Investigator
The University of Tennessee, Knoxville