Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty
追踪信息 | |||
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首次提交日期 ICMJE | August 20, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | October 2, 2003 | ||
预计主要完成日期 | December 31, 2022 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Osteolysis frequency change between 7 and 15 years[ Time Frame: Change between 7 to 15 years after surgery ] Osteolysis frequency (%) measured with computed tomography, Osteolysis size change between 7 and 15 years[ Time Frame: Change between 7 and 15 years after surgery ] Osteolysis size (cm3) measured with computed tomography |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty | ||
正式标题 ICMJE | Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients | ||
简要概况 | Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Prospective randomized study 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Active, not recruiting | ||
预计入组 ICMJE |
104 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | December 31, 2022 | ||
预计主要完成日期 | December 31, 2022 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - primary osteoarthritis - secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis) Exclusion Criteria: - inflammatory arthritis - hip joint infection | ||
性别 |
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年龄 | 最小年龄:35 Years ,最大年龄:64 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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IPD 共享声明 |
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责任方 | Per-Erik Johanson,Sahlgrenska University Hospital, Sweden | ||
研究赞助商 ICMJE | Sahlgrenska University Hospital, Sweden | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Sahlgrenska University Hospital, Sweden | ||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |