Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Spartan Stem, World Acetabular Cup and World Liner Survival Rate
研究概览
简要总结
The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.
详细描述
The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.
The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.
The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction.
Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.
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
- •patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
- •patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.
- •male and non-pregnant female patients aged 18-75
- •patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.
排除标准
- •patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
- •patient is a female of child-bearing age and not taking and not taking contraceptive pills
- •patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- •patient has a known or suspected metal sensitivity
- •patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
- •patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
- •patient is severely overweight with a BMI>40.
结局指标
主要结局
Spartan Stem, World Acetabular Cup and World Liner Survival Rate
时间窗: up to 2 years
The implant survival rate is based on removal of the device for any reason as determined following the Kaplan-Meier method.
次要结局
- Oxford Hip Score (OHS)(up to 2 years)