A Randomized Controlled Trial Comparing Modular Dual Mobility Inserts With Ceramic Multilayer Coating Versus Standard Polyethylene Inserts for Primary Total Hip Arthroplasty (THA) in a Cementless Acetabular Cup
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum metal ion analysis (Chromium)
研究概览
简要总结
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
详细描述
The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary coxarthrosis patients indicated for cementless total hip arthroplasty
- •Written informed patient consent
排除标准
- •Hip trauma or revision surgery
- •Rheumatoid or neurologic disease
- •Ongoing oncologic therapy
- •Preoperatively elevated Co or Cr serum levels >1.0 µg/L
- •Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
- •Acetabular cup size <52 expected
- •Patients not able to mentally or physically comply with the study demands and follow-up visits
- •Patients <18 years at surgery
- •Pregnancy
研究组 & 干预措施
Dual Mobility Cup
dual mobility articulation
干预措施: Dual Mobility Cup (Device)
Standard Acetabular component
standard articulation with polyethylene + vitamin E inlay and metal head
干预措施: Standard Acetabular component (Device)
结局指标
主要结局
Serum metal ion analysis (Chromium)
时间窗: 12 months after surgery
Chromium ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups
Serum metal ion analysis (Cobalt)
时间窗: 12 months after surgery
Cobalt ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups
次要结局
- Radiologic Evaluation: center of rotation(immediately postoperative, 3 months, 12 months and 3 years postoperative)
- Radiologic Evaluation: Radiolucencies around the cup(over follow-up period 3 months, 12 months and 3 years postoperative)
- Radiological Outcome: Heterotopic Ossification(over follow-up period 3 months, 12 months and 3 years postoperative)
- Change of functional outcome over three year follow-up period (Harris Hip Score)(3 months, 12 months and 3 years postoperatively)
- Gait analysis over time(preoperative, 3 months and 12 months postoperatively)
- Development of Patient satisfaction with surgery result over time(at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop))
- Radiologic Evaluation: Cup Inclination over time(immediately postoperative, 3 months, 12 months and 3 years postoperative)