NCT00689689已完成4 期
A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Revision
研究概览
简要总结
The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.
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
- Single (Participant)
入排标准
- 年龄范围
- 72 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
- •Revisions of failed osteotomies may be included
- •Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients > 72 years of age
排除标准
- •Patients with active infection
- •Revision cemented total hip replacement
- •Charcot joints
- •Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
- •C.D.H. with abnormally placed acetabuli or femoral canals
- •Fibromyalgia patients
研究组 & 干预措施
Fully Coated Prodigy Stem (AML)
Active Comparator
Total hip arthroplasty with fully coated prodigy stem (AML)
干预措施: Fully coated Prodigy stem (Device)
Cemented Endurance Hip Stem
Active Comparator
Total hip arthroplasty with cemented Endurance hip stem component
干预措施: Cemented Endurance Stem (Device)
结局指标
主要结局
Revision
次要结局
- Womac
- SF-12
研究者
研究点 (1)
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