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临床试验/NCT03951948
NCT03951948已完成不适用

Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 453 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
453
试验地点
1
主要终点
rate of reoperations

研究概览

简要总结

This retrospective observational study analyses the surgical performance, clinical and radiologic outcome as well as the rate of infections with a main focus on revision surgeries after primary implantation of the Optimys short stem femoral prosthesis.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018

排除标准

  • Clinical follow up at another Institution
  • Documented dissent in study participation

结局指标

主要结局

rate of reoperations

时间窗: one year follow-up period after Optimys femoral stem surgery

rate of reoperations after primary implantation of the Optimys short stem prosthesis

次要结局

  • rate of fractures(one year follow-up period after Optimys femoral stem surgery)
  • rate of infections(one year follow-up period after Optimys femoral stem surgery)
  • rate of cortical hypertrophy(at one year follow-up after Optimys femoral stem surgery)
  • pain at rest (yes/no)(at one year follow-up after Optimys femoral stem surgery)
  • subsidence(at one year follow-up after Optimys femoral stem surgery)
  • use of walking aids(at one year follow-up after Optimys femoral stem surgery)
  • anatomic alignment on anterior-posterior (ap) view in Degree°(at one year follow-up after Optimys femoral stem surgery)
  • pain under stress (yes/no)(at one year follow-up after Optimys femoral stem surgery)
  • use of analgetics (yes/no)(at one year follow-up after Optimys femoral stem surgery)
  • extent of periarticular ossification (PAO) according to Brooker classification system(at one year follow-up after Optimys femoral stem surgery)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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