Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Assessment of implant survivorship using Kaplan Meier curve
研究概览
简要总结
Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.
详细描述
All patients candidated to receive a total hip arthroplasty under 75 years old, who will receive a Mpact 3D Metal cup will be proposed to take part to the study. They will receive the same treatment in case they will not partecipate; the study is an observational study according to standard practice. The study aim to assess the long term peformance of the cup at 10 years after surgery. The patients will be visited at 6 months, 1, 5 and 10 years after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use
- •Patients who have signed the informed consent to participate in the study
排除标准
- •Minor patients, patients over 75 years of age at the time of primary surgery;
- •Any patient who is unable or unwilling to give informed consent to participate in the study.
结局指标
主要结局
Assessment of implant survivorship using Kaplan Meier curve
时间窗: 10 years
a Kaplan Meir survival curve will be calcuated
次要结局
- Assessment of Device stability throught a radiological exam(6 months, 1 year, 5 and 10 years)
- Assessment of the clinical outcome following total hip replacement using the Harris Hip score(6 months, 1 year, 5 and 10 years)
- Device Safety assessed through adverse event collection(up to 10 yrs follow-up)