NCT05186168进行中（未招募）不适用
The Corin MiniHip and Trinity Advanced Bearing Acetabular Cup System UK Clinical Surveillance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Corin
- 入组人数
- 546
- 主要终点
- Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up
研究概览
简要总结
The aim of the study is to provide long term follow up data on the performance and safety of the Corin MiniHip and Trinity acetabular cup over a 10-year period.
详细描述
To verify the ten-year clinical and radiographic performance of the Corin MiniHip and Trinity Advanced Bearing Acetabular System when used in patients under normal conditions of use.
To document the safety, evaluate patient satisfaction, quality of life and to determine the survivorship following intervention with the Corin MiniHip and Trinity Advanced Bearing Acetabular System at each follow-up visit.
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
- •A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or developmental dysplasia of the hip.
- •Avascular necrosis of the femoral head
- •All subjects must be between the age of 18 and 75 at the time of surgery to take part in this study
- •Scheduled for a primary total hip replacement.
排除标准
- •Active infection
- •Severe Obesity (BMI over 35)
- •Pregnancy
- •Mental illness
- •Grossly distorted anatomy (surgeon's discretion)
- •Osteomyelitis
- •Osteomalacia
- •Distant foci of infections
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Muscular atrophy or neuromuscular disease
- •Allergy to implant material
- •Marked bone loss or bone resorption
- •Patients without sufficient quantities of synovial fluid to allow for proper lubrication, such as patients with Sjogren's syndrome
- •Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock or poor skin coverage around the hip joint which would make the procedure inappropriate
- •Any case not described in the inclusion criteria
- •Any patient who cannot or will not provide informed consent for participation in the study
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
结局指标
主要结局
Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up
时间窗: 10 years
Survivorship measured via Kaplan-Meier (KM) curve
次要结局
- Minihip Stem radiographic performance up to 10-years(Baseline to 10 years)
- Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years(Baseline to 10 years)
- Oxford Hip Score (OHS) up to 10-year follow-up(Baseline to 10 years)
- Trinity acetabular cup radiographic performance up to 10-years(Baseline to 10 years)
- Harris Hip Score (HHS) up to 10-year follow-up(Baseline to 10 years)
- Hip- and device-related adverse events up to 10-year follow-up(Baseline to 10 years)
研究者
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