NCT01952067已完成不适用
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference in subsidence of femoral stems of 200 microns
研究概览
简要总结
The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.
Furthermore pain, postoperative outcome and patient satisfaction will be assessed.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring cemented primary total hip replacement.
- •Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
- •Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- •Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery
排除标准
- •Patients who require revision of a previously implanted total hip replacement (THR)
- •Patients who will receive a THR without cement
- •Patients who have had a prior procedure of osteotomy on the femur
- •Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI >35)
- •Patients with active or suspected infection
- •Patients with malignancy
结局指标
主要结局
Difference in subsidence of femoral stems of 200 microns
时间窗: change from 6th day postoperative to 24 months
Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem
次要结局
- EQ-5D-5L(change from 6th day postoperative to 24 months)
- Visual Assessment Scale (VAS) for pain(change from 6th day postoperative to 24 months)
- Oxford Hip Score(change from 6th day postoperative to 24 months)
- Harris Hip Score (HHS)(change from 6th day postoperative to 24 months)
- Merle D'Aubigne scale(change from 6th day postoperative to 24 months)
研究者
研究点 (1)
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