A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 5
- 主要终点
- Change from baseline Harris Hip Scores (HHS)
研究概览
简要总结
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- •Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
- •Patients must be willing to comply with the pre and post-operative evaluation schedule
排除标准
- •Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
结局指标
主要结局
Change from baseline Harris Hip Scores (HHS)
时间窗: Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year
Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores
Change from baseline of implant survivorship
时间窗: Post-operative 3 or 6 months, 1 year, 2 year, and 5 year
Assessment of bone fracture, implant fracture, neck reabsorption
Change in baseline of Complications
时间窗: Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.
Assessment of Adverse events and serious adverse events
Change in baseline fixation and wear
时间窗: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Radiographic analysis by measuring Radio Lucent Lines
Change in baseline fixation
时间窗: Post-operative 3 or 6 months, 1 year, 2 year and 5 year
Radiographic analysis by measuring implant fixation in millimeters
次要结局
未报告次要终点