Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Implant survival: Ratio of the number of participants alive with the complete index hip prosthesis in position at 2-year follow-up, over their initial numberprosthesis in position at 2-year follow-up, over their initial number.
研究概览
简要总结
This is a single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty with a SYMBOL CUP DM HA hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of that implant at two-year follow-up.
详细描述
Description according to PICOS framework:
Patients:
- Adult men and women requiring a primary total hip arthroplasty
Intervention:
- Primary THA with SYMBOL CUP DM HA hemispherical dual mobility acetabular implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients with total hip implant using hemispheric dual-mobility SYMBOL CUP DM HA
- •Operation performed by the primary investigator
- •Delay between index operation and March 1 2018 has reached 2 years
排除标准
- •patient refusal to participate in the study
- •minors (age < 18 years)
- •patients under guardianship
结局指标
主要结局
Implant survival: Ratio of the number of participants alive with the complete index hip prosthesis in position at 2-year follow-up, over their initial numberprosthesis in position at 2-year follow-up, over their initial number.
时间窗: 2 years as of index operation
This is the ratio of the number of participants who are alive with the complete index hip prosthesis in position at a given follow-up time (numerator) over the initial number of those participants from the date they received the index hip prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each participant index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the hip prosthesis in place. The longest duration between the index operation and the final assessment is 2 years.
次要结局
- Number of patients with one or several post-operative adverse events and count of each Serious adverse event and aggregate count of adverse events(2 years as of index operation)
- Harris Hip Score (HHS) at baseline and 1-year follow-up(1 year as of index operation)
- The modified Harris Hip Score (modified HHS) at baseline, 1-year and 2-year follow-up(2 years as of index operation)
- Devane classification at baseline, 1-year and 2-year follow-up.(2 years as of index operation)
- Charnley classification at baseline, 1-year and 2-year follow-up.(2 years as of index operation)