跳至主要内容
临床试验/NCT04592939
NCT04592939Unknown不适用

Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2020年10月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
169
试验地点
2
主要终点
Postoperative Complications

研究概览

简要总结

This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • femoral revision patients with the use of a modern titanium, fluted, tapered stem.

排除标准

  • include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing

结局指标

主要结局

Postoperative Complications

时间窗: 1 year

radiographic measurements of subsidence of the stem

Return to function

时间窗: 1 year

time to return to baseline ambulatory status

Implant survival

时间窗: 1 year

re-revision rates within one year

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 (2)

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