A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 383
- 试验地点
- 18
- 主要终点
- Absence of Revision for the Trident II Tritanium Acetabular Shell
研究概览
简要总结
The purpose of this study is to review the performance and success rate of an FDA approved 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.
详细描述
This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- •B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.
- •C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.
- •D. Patient is a candidate for a primary cementless total hip replacement.
- •E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
排除标准
- •F. Patient has a Body Mass Index (BMI) ≥
- •G. Patient is diagnosed with Inflammatory Arthritis.
- •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 neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •J. 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.
- •K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- •M. Patient has had previous open surgery to the affected joint, not including arthroscopy.
- •N. Patient requires implantation of a constrained liner.
- •O. Patient has a known sensitivity to device materials.
- •P. Patient is a prisoner.
研究组 & 干预措施
Trident II Tritanium Acetabular Shell
The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application.
干预措施: Trident II Tritanium Acetabular Shell (Device)
结局指标
主要结局
Absence of Revision for the Trident II Tritanium Acetabular Shell
时间窗: 5 years
To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.
Absence of Revision for the Trident II Tritanium Acetabular Shell
时间窗: 5 years
To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.
次要结局
- Radiographic Stability(6 weeks, 3-6 months, 1, 2, 5, 7, 10 years)
- All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell(10 years)