跳至主要内容
临床试验/NCT03898544
NCT03898544已完成不适用

Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Femorotibial mechanical axis (varus, valgus) analysis

研究概览

简要总结

The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.

研究设计

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

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

  • Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)
  • Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

排除标准

  • Septic failure
  • Second or more failure in the revision group
  • Associated surgical procedure as osteotomy, allograft...
  • Not full weight bearing postoperatively
  • Refusal to participate

结局指标

主要结局

Femorotibial mechanical axis (varus, valgus) analysis

时间窗: at 6 months postoperatively

These parameters are measured with the KneeKG system during the walking

Walking speed

时间窗: at 6 months postoperatively

These parameter is measured with the KneeKG system

range of motion (flexion, extension) analysis

时间窗: at 6 months postoperatively

These parameters are measured with the KneeKG system during the walking

internal/external rotation analysis

时间窗: at 6 months postoperatively

These parameter is measured with the KneeKG system during the walking

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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