NCT04599582已完成不适用
Prospective Randomised Study of a New Anteverted Uncemented Stem. Randomised Study Between the SP-CL and the Corail Stem With the Use of a Delta Cup.
Sahlgrenska University Hospital0 个研究点目标入组 80 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Oxford hip score
研究概览
简要总结
Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoartritis Secondary osteoartritis
排除标准
- •Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.
研究组 & 干预措施
SP-CL
Active Comparator
干预措施: Hip Arthroplasty (Device)
Corail
Active Comparator
干预措施: Hip Arthroplasty (Device)
结局指标
主要结局
Oxford hip score
时间窗: two years
Patient reported outcome measure
次要结局
- Conventional X-rays(two years)
- DXA(Two years)
- RSA-examination(two years)
- Harris hip score(two years)
研究者
Johan Karrholm
Professor
Sahlgrenska University Hospital
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