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临床试验/NCT02358434
NCT02358434已完成不适用

Kinematics Analysis: Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty With the ATTUNE TM Knee System

Dr. Renate List1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles

研究概览

简要总结

The proposed study is a retrospective, observational study. A group of 5 subjects with the AttuneTM cruciate retaining (CR) fixed bearing total knee arthroplasty (TKA) are analysed during level walking, a deep knee bend, sitting down onto a chair, standing up from a chair and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral TKA motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. The obtained information helps the manufacturer (DePuy) to evaluate, bring to market and advance the implant. Furthermore the information will be integrated in a model, which will be developed at the Center for Orthopaedic Engineering, University of Denver. By means of this model, different conditions such as the use of an advanced prosthesis design can be simulated and tested.

The objective of this study is in a first step to demonstrate the capability of data collection and analysis of level gait, deep knee bend, sitting down onto a chair, standing up from a chair and stair descent on a limited sample size of five subjects. Secondly to quantify and describe the three-dimensional kinematics for the cruciate retaining (CR), fixed bearing AttuneTM TKA during daily activities such as those mentioned.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral TKA (ATTUNETM) due to osteoarthrosis (OA)
  • Body mass index (BMI) ≤ 33
  • Good clinical outcome, Knee injury and Osteoarthritis Outcome Score (KOOS) > 70
  • No or very low Visual Analog Scale for Pain (VAS) < 2
  • At least one year post-op
  • Standardized general health survey score (SF-12) within the normal range for people in their age group

排除标准

  • Actual significant problem on lower extremities
  • Misaligned TKA
  • Any other arthroplasty at the lower extremities
  • Patient incapable to understand and sign informed consent
  • Incapable of performing the motion tasks
  • Pregnancy

结局指标

主要结局

Relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles

时间窗: 3 hours

The primary outcome of this pilot study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles during level walking, stair descent, standing up from a chair, sitting onto a chair and deep knee bend.

次要结局

未报告次要终点

研究者

发起方
Dr. Renate List
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Renate List

Dr. sc. ETH Zurich

Institute for Biomechanics, ETH Zürich

研究点 (1)

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