STEISURE - Trident II - A Registerbased Multicentric Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Implant survival at 3 years
研究概览
简要总结
In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.
详细描述
Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary hip replacement
- •Eligible for uncemented fixation of the acetabular component
- •Suitable for one of the stem designs from Stryker Orthopaedics
- •Accepts follow-up according to the study protocol
排除标准
- •Difficulties to understand written information due to language problems or other reasons
- •Use of augments needed
- •Acute hip fracture
- •Tumor in the hip joint
结局指标
主要结局
Implant survival at 3 years
时间窗: 3 years
Kaplan Meier survival data, cup revision and risk of revision used as endpoints
次要结局
- EQ-5D(10 years)
- Adverse events using the regional VEGA database(10 years)
- Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients(CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement)
- Plain radiographs in a sub-cohort of patients(10 years)
- Implant survival at 10 years(10 years)
- Adverse events using the national patient register(10 years)
- Oxford Hip Score(10 years)
- Forgotten Joint Score(10 years)
研究者
Maziar Mohaddes Ardebili
Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden