试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- clinical evaluation
研究概览
简要总结
Although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. Patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. The aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.
详细描述
The investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral hip arthritis
- •Age up to 65 years
- •Body mass index (BMI) up to 35
- •Modified Charnley comorbidity classification equal to A
排除标准
- •Neurological deficit (e.g. Parkinsonism, stroke)
- •Bone type c not fit for cementless fixation
- •Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis)
- •Any patient with psychiatric disorders
结局指标
主要结局
clinical evaluation
时间窗: about 5 years
WOMAC score
patient's satisfaction
时间窗: about 5 years
measurement by patient's reported outcomes measures
pain assessment
时间窗: about 5 years
VAS score
次要结局
未报告次要终点
研究者
ahmed m. samy
assistant professor
Tanta University