In Vivo Kinematics for Subjects Implanted With Klassic TKA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Axial Rotation (AR) During Deep Knee Bend
研究概览
简要总结
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr. Aaron Hofmann of the Hofmann Arthritis Institute's Center for Precision Joint Replacement. This is the location from which all participants will be recruited and where fluoroscopy data collection will occur. Participants will undergo fluoroscopic surveillance of their implanted knee using a C-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.
详细描述
Enrollment will be increased to 24 subjects 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. At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee. The kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off
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 a Klassic knee system.
- •Subjects must be at least six months post-operative.
- •Participants must be judged clinically successful with their most recent (new) Knee Society "Knee Score" equal to or greater than
- •Participants must be able to perform a deep knee bend.
- •Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
- •Must speak English.
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 the required type of knee implant.
- •Bilateral subjects (i.e., patients with both knees implanted)
- •Subjects who are unable to perform a deep knee bend.
- •Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
- •Subjects who do not speak English
结局指标
主要结局
Axial Rotation (AR) During Deep Knee Bend
时间窗: at least 6 months post-operative
Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.
Maximum Weight-bearing Flexion During Deep Knee Bend
时间窗: at least 6 months post-operative
Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.
Medial Condyle Translations During Deep Knee Bend Activity.
时间窗: at least 6 months post-operative
Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
Lateral Condyle Translations During Deep Knee Bend Activity
时间窗: at least 6 months post-operative
Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.
次要结局
未报告次要终点
研究者
Richard Komistek
Principle Investigator
The University of Tennessee, Knoxville