A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 19
- 主要终点
- Number of Cases Free From Trident II Acetabular Shell Revision
研究概览
简要总结
The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- •B. Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation.
- •C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
- •D. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
排除标准
- •E. Patient has a Body Mass Index (BMI) >
- •F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- •I. Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
- •K. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- •L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.
结局指标
主要结局
Number of Cases Free From Trident II Acetabular Shell Revision
时间窗: 6 Weeks, 3-6 Months, 1 Year and 2 Years
To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative.
次要结局
- Radiographic Stability(6 Weeks and 3-6 Months)