NCT04688593招募中不适用
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
研究概览
简要总结
The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results.
The MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis system under routine condition and to determine the satisfaction of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
- •Age ≥ 18 years
- •Fully signed patient informed cons
排除标准
- •Revisions
- •Body Mass Index (BMI) ≥ 40 kg/m²
- •Patient who is foreseeable not able to understand the study and the study-related circumstances
- •Patients who is foreseeable non-compliant to the treatment and the follow-ups
- •Pregnant or breast-feeding women
结局指标
主要结局
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
时间窗: 10-years
calculated with Kaplan-Meier method.
次要结局
- Rate of failed osteointegrated stems(3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Change of postoperative cup position(3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint(3 months, 1 year, 3, 5, 7 and 10 years)
- Revision rates of the MobileLink acetabular cup system shell(s) with revision for any reason as the endpoint(3 months, 1 year, 3, 5, 7 and 10 years)
- Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint(10 year)
- Revision rates of the MobileLink acetabular cup system inserts (Ceramic, XLINKed, E-Dur) with revision for any reason as the endpoint(3 months, 1 year, 3, 5, 7 and 10 years)
- Revision rates of the combined LINK hip stem(s) with revision for any reason as the endpoint(3 months, 1 year, 3, 5, 7 and 10 years)
- Change of baseline hip functionality(pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Rate of complications and re-operations of the hip joint(3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Rate of failed osteointegrated cups(3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Change of postoperative stem position(3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Occurence of heterotopic ossifications(3 months, 1 year, 3, 5, 7 and 10 year follow-up)
- Type and rate of complications with the used instruments related to usability and sterilization(intraoperatively)
研究者
研究点 (2)
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