Origin Stem and Logical Cup Post Market Clinical Follow-up
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Stem and Cup Survival Rate
研究概览
简要总结
The aim of the study is to monitor the performance of the Signature Orthopaedics Origin Stem and Logical Acetabular Cup as part of 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 Origin Stem and Logical Cup when used for primary total hip arthroplasty at 2 years follow-up. This prospective follow-up series is necessary to obtain data specific to the Origin Stem and Logical Cup considering their relatively recent launch to the market.
The study includes pre-operative, operative, discharge, 1 year post-operative and 2 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. In particular, 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, and radiographic analysis 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)
- •patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- •patient is female of child-bearing age and not taking contraceptive precautions
- •patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- •patient has inflammatory joint disease (e.g. rheumatoid arthritis)
- •patient has known moderate to severe renal deficiency
- •patient has a known or suspected metal sensitivity
- •patient is immuno-suppressed with diseases such as AIDS or is receiving high dose of corticosteroids
- •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
Stem and Cup Survival Rate
时间窗: up to 2 years
The implant survival rate 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)
- Radiographic Analysis(up to 2 years)