NCT01842724进行中（未招募）不适用
Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年8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
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PRWHE (Patient rated Wrist and Hand Evaluation score)
研究概览
简要总结
The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
- •Age 18-70 years
- •ASA class 1-3
排除标准
- 未提供
研究组 & 干预措施
Motec total wrist arthroplasty
Active Comparator
干预措施: Motec total wrist arthroplasty (Procedure)
Remotion total wrist arthroplasty
Active Comparator
干预措施: Remotion total wrist arthroplasty (Procedure)
结局指标
主要结局
PRWHE (Patient rated Wrist and Hand Evaluation score)
时间窗: 24 months postop
PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function
次要结局
- Implant migration(24 months postop)
- Implant loosening(24 months postop)
- Wrist movement(24 months postop)
- Postoperative complications(24 months postop)
- Grip Strength(24 months postop)
- Quick-DASH(24 months postop)
- Pain in affected wrist(24 months postop)
- intraoperative complications(intraoperative)
- Periprosthetic bone mineral density(24 months postop)
- Reoperations(24 months postop)
研究者
Trygve Holm Glad
MD
Oslo University Hospital
研究点 (1)
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