Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Implant Survival: Acetabular Cup Survival at 2-year Follow-up
研究概览
简要总结
This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.
详细描述
Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) framework:
Patients:
- Adult men and women requiring a total hip arthroplasty
Intervention:
- THA with SYMBOL CUP DMR HA or SYMBOL CUP DM CEM hemispherical dual mobility acetabular implants.
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 DMR HA or SYMBOL CUP DM CEM
- •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: Acetabular Cup Survival at 2-year Follow-up
时间窗: 2 years as of index operation
This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint 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 acetabular 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)