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临床试验/NCT02519218
NCT02519218已完成不适用

Outcomes Registry of Patients With Osteoarthritis and Varus Malalignment of the Knee Treated With Ellipse Intramedullary High Tibial Osteotomy (IM HTO) Nail System

Ellipse Technologies, Inc.0 个研究点目标入组 6 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
主要终点
Target vs. Actual Correction

研究概览

简要总结

The purpose of this study is to collect outcomes data in patients implanted with the Ellipse IM HTO Nail System.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient implanted with the Ellipse IM HTO Nail System for osteoarthritis and varus malalignment of the knee
  • Patient signs informed consent for the use of their personal private data.

排除标准

  • Patient is currently enrolled in another clinical trial for high tibial osteotomy.

结局指标

主要结局

Target vs. Actual Correction

时间窗: Participants will be followed for the duration of consolidation (bone healing), an average of 4 months

Measured as either weight-bearing line (percent) or HKA angle (degrees)

次要结局

  • Change in Weight-Bearing Line(2-years post-operative)
  • Change in Hip-Knee-Ankle Angle(2-years post-operative)
  • Change in Tibial Slope(2 years post-operative)
  • Time to full weight-bearing(Participants will be followed through 2 years post-operative)
  • Bone Healing(2 years post-operative)

研究者

申办方类型
Industry
责任方
Sponsor

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