RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-lock, Corail and Deltamotion Hip Replacement Components: a Single-blinded Randomised Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).
研究概览
简要总结
Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 65 years and men aged between 18 and 70 years.
- •Participant is willing and able to give informed consent for participation in the study.
- •Diagnosed with hip osteoarthritis.
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
排除标准
- •Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
- •Patients who have significant co-morbidities that would make follow-up difficult or uncomfortable.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
研究组 & 干预措施
DePuy Tri-Lock®
Total hip replacement with DePuy Tri-Lock® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care.
干预措施: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component (Device)
DePuy Corail®
Total hip replacement with DePuy Corail® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care.
干预措施: DePuy Corail® femoral stem + Deltamotion® acetabular component (Device)
结局指标
主要结局
Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).
时间窗: 3 years
次要结局
- Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component(3 years)
- Change in Oxford Hip Score (OHS) at three years.(3 years)
- Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).(3 years)
- Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.(1 year)