Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean head penetration from baseline to 5 year follow-up
研究概览
简要总结
The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary idiopathic arthritis,
- •Eligible for uncemented total hip arthroplasty
- •40 to70 years of age,
- •Cup size of 54mm and above
排除标准
- •Anteversion where non-standard stem can be used,
- •Dysplasia (Center-edge angle of Wiberg < 20°),
- •Malignant condition
- •Prior radiotherapy
- •Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
- •Complications during surgery (requiring screws in shell or femoral cerclage)
研究组 & 干预措施
E-Poly/32 mm
E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
干预措施: E-Poly liner (Device)
E-Poly/32 mm
E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
干预措施: 32 mm femoral head (Device)
E-Poly/36 mm
E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
干预措施: E-Poly liner (Device)
E-Poly/36 mm
E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
干预措施: 36 mm femoral head (Device)
ArComXL/32 mm
ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
干预措施: ArComXL liner (Device)
ArComXL/32 mm
ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
干预措施: 32 mm femoral head (Device)
ArComXL/36 mm
ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
干预措施: ArComXL liner (Device)
ArComXL/36 mm
ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
干预措施: 36 mm femoral head (Device)
结局指标
主要结局
Mean head penetration from baseline to 5 year follow-up
时间窗: From baseline to 5 years
Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up
次要结局
- Mean cup migration form baseline to 5 year follow-up(From baseline to 5 years)
- Mean change in clinical outcome score from baseline to 5 year follow-up(From baseline to 5 years)
研究者
Joseph Abdalla Nommesen El-Sahoury
Research assistant
Odense University Hospital