"Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Stability of primary total hip arthroplasty
研究概览
简要总结
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).
We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.
详细描述
This study is a monocentric study, randomized and controlled including two types of hip stems: SL PLUS MIA (control group) and SL PLUS (study group).
Each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss.
Patients will be followed after
- 6 weeks
- 6 months
- 12 months
- 24 months. Radiographs are taken in a-p and lateral view using a standard protocol. Primary and secondary stability of both hip stems will be analyzed using the EBRA software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the completion of the two year follow-up.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient needs primary total hip arthroplasty with SL-PLUS (standard or lateralized depending on bone morphology)
- •Age at surgery : 18-80 years old
- •Patient has social security number
- •Patient gives Informed Consent (IC) by signing the IC form and patient is willing to attend the follow-up control
排除标准
- •Patient's BMI is over 35
- •Patient has bone tumors that can affect implant stability
- •Patient needs cortical steroid treatment
- •Patient needs hip revision arthroplasty
- •Patient has general inflammation that could affect bone quality
- •Patients classified Charnley C
结局指标
主要结局
Stability of primary total hip arthroplasty
时间窗: 24 months
Study compares the stability of two types of hip stems using the Femoral Component Analysis (FCA-EBRA)method. 4 images of a-p pelvic view will be collected over a 2-year period: at 6 weeks, 6, 12 and 24 months.
次要结局
- Harris Hip Score(24 months)
- Oxford Hip Score(24 months)