NCT01614028Unknown不适用
Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem
适应症
试验速览
- 阶段
- 不适用
- 试验地点
- 4
- 主要终点
- Short term hip function
研究概览
简要总结
This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.
研究设计
- 研究类型
- Interventional
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
- •Patient signed an IRB, study specific informed patient consent.
- •Patient is a male or non-pregnant female age 18 years or older at the time of study device implantation.
- •Patient has primary diagnosis of non-inflammatory degenerative joint disease.
- •Patient is a candidate for primary cementless total hip replacement.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has a Body Mass Index (BMI) > 40 Kg/m
- •Patient has an active or suspected infection at the time of device implantation.
- •Patient is immunologically suppressed.
- •Patient requires revision surgery of a previously implanted total hip replacement.
- •Patient has a known sensitivity to device materials.
结局指标
主要结局
Short term hip function
时间窗: within six weeks post-operative
Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit
次要结局
- Short-Term Pain Levels of direct anterior and anterolateral surgical approaches
研究者
研究点 (4)
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