NCT04592939Unknown不适用
Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 169
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Group 1: immediate weight bearing
Other
干预措施: immediate weight bearing after surgery (Procedure)
Group 2: 6 week toe touch weight bearing
Other
干预措施: 6 weeks of toe-touch weight bearing after surgery (Procedure)
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
研究点 (1)
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