NCT01420900已完成不适用
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- All noises from THA
研究概览
简要总结
The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for uncemented THA under the age of 65 years.
排除标准
- •Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
- •Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
- •Severely impaired level of function due to other physical deficiencies than the hip.
- •Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- •Earlier primary THA or revision THA in the contralateral hip.
- •Pathology requiring another prosthesis concept than the below mentioned.
- •Body mass index greater than 35.
研究组 & 干预措施
ABG II / Trident
Active Comparator
干预措施: THA with ABG II / Trident (Device)
CLS / Trilogy
Active Comparator
干预措施: THA with CLS / Trilogy (Device)
结局指标
主要结局
All noises from THA
时间窗: One year
次要结局
- Life quality(One year)
研究者
研究点 (1)
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