Metal Ion Levels in Stryker Trident II Tritanium System with MDM Liner, Ceramic Head, and SecurFit Advanced Stems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup
研究概览
简要总结
Metal Ions levels of cobalt, chromium, and titanium in 40 patients preoperatively and at least 1 year status post total hip replacement with the Trident II Tritatnium system using an MDM liner and ceramic head. Are cobalt, chromium, and titanium levels in patients who undergo a total hip replacement with a Trident II Tritanium system, MDM liner, and ceramic head normal one year after surgery? Investigators expect to find normal levels of metal ions (cobalt, chromium, and titanium) after total hip replacement using Trident II Tritanium cups with an MDM liner and a ceramic head. The primary outcome (PO) is blood metal ion levels of cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for Special Surgery laboratory. The bloods will be drawn at a preoperative visit and at a one year visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will be undergoing a total hip replacement with a Stryker Trident II cup
- •Patients have signed an Institutional Review Board (IRB) approved consent form
- •Patient is 21-80
- •Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease
- •Patient is willing and able to comply with postoperative scheduled clinical evaluations.
排除标准
- •Patients who have not been consented as part of the Collaborative Orthopaedic Replacement Registry (CORRe) database
- •Patients with other joint replacements (shoulder/knee)
- •Patients with bilateral hip replacements
- •International Patients
结局指标
主要结局
Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup
时间窗: 1 year
The primary outcome (PO) is blood metal ion levels of cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for Special Surgery laboratory.
次要结局
未报告次要终点