RSA-measured in Vivo Wear, Migration and Micromotion in the Corin Mini-Hip/Metafix and ECIMA Polyethylene.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Radiostereometric Analysis (RSA) measured migration (mm)
研究概览
简要总结
The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ECIMA Highly Cross-linked polyethylene.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men between the ages of 18 and 65 years old.
- •Scheduled to receive a hip replacement
- •Willing and able to give informed consent for participation in the study.
- •Diagnosed with hip osteoarthritis
- •Able (in the investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study
排除标准
- •The participants may not enter the study if ANY of the following apply:
- •Inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
- •Significant comorbidities that would make follow up difficult or uncomfortable
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk due to participation in the study, may influence the result of the study, or the participants ability to participate in the study.
结局指标
主要结局
Radiostereometric Analysis (RSA) measured migration (mm)
时间窗: Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively
The images taken at each time point will be compared with the baseline to assess implant migration. Therefore the outcome is change in implant position measured using RSA.
次要结局
- Dynamically Inducible Micromotion DIMM (mm)(Measured at 6, 12, 24 and 36 months post-operatively)
- Implant failure for femoral and acetabular components(Observed at 3, 6, 12, 18, 24 and 36 months post-operatively)
- Change in Oxford Hip Score(Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively)
- Change in Harris Hip Score(Measured pre-operatively (baseline) and at 3, 6, 12, 18, 24 and 36 months post-operatively)