JPRN-UMIN000006224
已完成
未知
Evaluation of efficiency and safety of a new hip arthroplasty implant(AMU001)for patients with hip joint diseases - Clinical study of a new prosthesis for total hip arthroplasty (AMU001)
Asahikawa Medical University Hospital Orthopaedics0 个研究点目标入组 30 人2011年9月1日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoarthritis of the Hip, Osteo necrosis of the Femoral Head, Rheumatoid arthritis
- 发起方
- Asahikawa Medical University Hospital Orthopaedics
- 入组人数
- 30
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- 未提供
排除标准
- •(1\) Patient had previously received hip prosthesis in the same hip joint. (2\) Patient received artificial joint prosthesis in lower extremity within 180 days. (3\) In the other side of the hip; 1\) loosening of total hip arthroplasty or hemiarthroplasty 2\) osteotomy or soft tissue release around hip joint is scheduled within one year (4\) Charnley category C (5\) Body weight\>\=80kg, BMI\>\=30 (6\) Severe osteoporosis (7\) Abscess or infection around hip joint (8\) Metal allergy (9\) It is difficult to follow the hip precautions due to neurological disorder, mental illness, alcohol dependence, or drug abuse. (10\) joined other clinical trial within 90 days (11\) in pregnancy or scheduled to become pregnant during this clinical trial. (12\) it is not possible to stop to use anticoagulant or antiplatelet drug from one week before surgery. (13\) Patient who is determined to be excluded from the clinical trial due to any reasons by the study doctor.
结局指标
主要结局
未指定
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