Comparing Hollow and Solid Centralizer Designs When Using a Polished, Collarless, Tapered Hip Prosthesis Stem (MS30). A Prospective, Randomized, Multicenter Study Evaluated by RadioStereometric Analysis (RSA).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Radiostereometric Analysis (RSA)
研究概览
简要总结
The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the hip necessitating primary hip replacement
- •Charnley classification group A and B
- •Age 60 - 85 years old at the inclusion time of the study.
排除标准
- •Secondary osteoarthritis
- •Rheumatoid arthritis
- •Malignant disease
- •Severe osteoporosis
- •Earlier fracture or operation in the hip to be operated on
- •Peroperative fracture
- •Ongoing corticosteroid (oral) or immunosuppressive medication
- •Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
研究组 & 干预措施
Hollow Centralizer
The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.
干预措施: Hollow Centralizer (Procedure)
Hollow Centralizer
The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.
干预措施: MS-30 femoral stem (Device)
Solid Centralizer
The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.
干预措施: Solid Centralizer (Procedure)
Solid Centralizer
The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.
干预措施: MS-30 femoral stem (Device)
结局指标
主要结局
Radiostereometric Analysis (RSA)
时间窗: The first postoperative day, 6 months, 1, 2, 5 and 10 years
This will measure the change in stem migration over time and be indicative of long term result.
次要结局
- x-ray(The first postoperative day, 6 months, 1, 2, 5 and 10 years)
- Hip specific questionnaire(Preoperatively, 1, 2, 5 and 10 years)
- General health questionnaire(Preoperatively, 1, 2, 5 and 10 years)