NCT03260465进行中（未招募）不适用
A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Wear Rate
研究概览
简要总结
This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in combination with the optimys short stem. Wear rate and migration is assessed with roentgen stereophotogrammetric analysis (RSA) measurements.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient.
- •Patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or 56mm)
- •Patients between the ages of 50 and 75 inclusive
- •Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
排除标准
- •Patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head
- •Patients that offer no guarantee for regular follow-up controls
- •Patients that have a revision surgery
- •Patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis
- •Patients that had a previous osteotomy of the femur or pelvis
- •Pregnant women or those seeking to become pregnant
- •Patients with a history of active infection
结局指标
主要结局
Wear Rate
时间窗: 3 years
The principal purpose of this study is to compare the modular seleXys PC Cup with a vitamys inlay to the monoblock RM Pressfit vitamys cup by means of wear rate. In addition, the migration of the two cups and the optimys stem, respectively, will be evaluated.
次要结局
未报告次要终点
研究者
研究点 (2)
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