The 10-year Follow-up of the Delta-TT Trial: Stability of the Delta-TT Cup with Polyethylene Insert Compared to the Delta-TT Cup with Ceramic Insert.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner.
研究概览
简要总结
This 10-year follow-up study aims to further investigate long-term migration patterns of the uncemented Delta-TT cup and H-MAX S stem, comparing outcomes between ceramic and polyethylene liners. Given the predictive value of early RSA migration patterns at the 2-year mark for identifying implants at risk of aseptic loosening, we hypothesize that the Delta-TT cup will demonstrate good stability at the 10-year postoperative mark. Besides, it is hypothesized that migration of Delta TT-cups is comparable between ceramic and polyethylene liners.
The primary objective of this study is to measure the long-term stability of the Delta TT cup, combined with either a ceramic or cross-linked polyethylene liner, by means of RSA at 10-years postoperatively.
Secondary objectives are to measure long-term stability of the H-MAX S stem, by means of RSA at 10-year postoperatively. Furthermore the study aims to measure implant survival rates and patient-reported outcomes for both the Delta-TT cup and H-MAX S stem, comparing outcomes between the ceramic and polyethylene group.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the initial Delta-TT trial
排除标准
- •Patient is unable or unwilling to sign the Informed Consent specific to this study.
- •Patient is unsuitable for participation in the study based on the investigator's judgement.
结局指标
主要结局
Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner.
时间窗: 10 Years
Measured in 3D translations and rotations by means of Radiostereometric X-ray images at 10-years postoperatively. Data will be summarized by treatment group. A mixed model analysis will be performed to assess cup migration, with liner type (polyethylene vs. ceramic) as the primary independent value. The primary outcome is the effect of the liner type on implant migration. Differences are considered significant for p-values below 0.05.
次要结局
- Long-term (10-year) migration pattern of the H-MAX S Stem compared between a ceramic and polyethylene liner.(10 years)
- Implant survival of the Delta TT cup and H-MAX S stem.(10 years)
- Radiographic signs of osteolysis around the Delta-TT cup.(10 years)
- Radiographic signs of osteolysis around the H-Max S stem.(10 years)