ACTRN12622000003774招募中未知
A post-market clinical investigation to evaluate clinical and patient-reported outcomes following a total hip arthroplasty surgery with Trinity™ Dual Mobility System in patients with hip osteoarthritis - Prospective Group
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •The individual has signed a Patient Informed Consent Form (PICF), specific to this clinical investigation, and approved by the Human Research Ethics Committee;
- •Both genders;
- •Age greater than or equal to 18 years old;
- •The individual clinically qualifies for Trinity™ Dual Mobility System with a Corin Femoral Stem based on physical examination and medical history.
- •The individual is willing to comply with the required protocol for follow-up visits.
- •Additional inclusion criteria for patients participating in the metal-ion analysis:
- •Willing to provide blood samples.
排除标准
- •Subjects under guardianship;
- •Subjects with any physical or psychological condition which would impair clinical investigation participation;
- •Having previous or current hip infection and or a history of metal sensitivity;
- •Having abnormal renal function
- •Any patient pregnant or with plans to become pregnant during the course of the clinical investigation.
- •Additional exclusion criteria for patients participating in the metal-ion analysis (from the prospective group):
- •Presence of any metal-containing implant in the body outside of the oral cavity
- •Taking chromium supplements.
- •Participants who are not willing or able to provide a blood sample
研究者
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