此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

In Vivo Determination of 3D Patellofemoral Mechanics (Patella)

2019年10月17日 更新者：Richard Komistek、The University of Tennessee, Knoxville
This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints. These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Colorado
      • Denver、Colorado、美国、80210
        • Porter Adventist Hospital
      • Denver、Colorado、美国、80210
        • Colorado Joint Replacement
    • Tennessee
      • Knoxville、Tennessee、美国、37996
        • Perkins Hall
      • Knoxville、Tennessee、美国、37996
        • Science and Engineering Research Facility

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.

描述

Inclusion Criteria:

  1. Patients must be at least six months post-operative.
  2. Potential subjects will have a body weight of less than 250 lbs.
  3. Candidates must have an AKS score >70 post-operatively.
  4. Patients must have passive flexion of at least 100.
  5. Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
  6. Must be willing to sign both Informed Consent and HIPAA forms.

Exclusion Criteria:

  1. Pregnant females.
  2. Subjects not meeting study requirements.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：仅案例
  • 时间观点：追溯

队列和干预

团体/队列
干预/治疗
Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
设备：Subjects implanted with DePuy LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Knee Prosthesis Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
设备：Subjects implanted with DePuy Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Control
Subjects with normal knees

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Patella Flexion With Respect to Femur
大体时间：Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patella Rotation With Respect to Femur
大体时间：Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patella Tilt With Respect to Femur
大体时间：Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants.
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Normalized Medial Patella Contact Point Translation
大体时间：Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Normalized Lateral Patella Contact Point Translation
大体时间：Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."
Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Tennessee, Knoxville

合作者

DePuy Orthopaedics

调查人员

  • 首席研究员：Richard D. Komistek, Ph D、The University of Tennessee
  • 首席研究员：Douglas Dennis, MD、Colorado Joint Replacement, Porter Adventist Hosp

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年2月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2011年2月3日

首先提交符合 QC 标准的

2011年2月4日

首次发布 (估计)

2011年2月7日

研究记录更新

最后更新发布 (实际的)

2019年10月29日

上次提交的符合 QC 标准的更新

2019年10月17日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 10035/IIS-000126
  • R011373372 (其他赠款/资助编号：DePuy Orthopaedics)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅