NCT00249054已完成不适用
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
Frederiksberg University Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
研究概览
简要总结
This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:
Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.
Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II,DEXA-scanning:
- •lower limit for a 55 years old women,
- •MRI normal
- •vitality in caput
- •willing to return for follow-up evaluations.
排除标准
- •collum femoris < 2 cm
- •large cysts in caput (> 1 cm)
- •mismatch between caput and acetabulum
- •caput necrosis
- •treatment with medicine which affects bone metabolism
- •impaired kidney function.
结局指标
主要结局
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
时间窗: 10 year follow up
follow with intervals of 1 to 3 years for determination of function and prosthesis survival
次要结局
未报告次要终点
研究者
Arne Borgwardt
Head of Dpt
Frederiksberg University Hospital
研究点 (2)
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