A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 275
- 试验地点
- 14
- 主要终点
- Absence of Acetabular Revision
研究概览
简要总结
This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface.
The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.
详细描述
The Tritanium® Acetabular Shell, cleared for use under FDA 510(k) K081171, is a hemispherical acetabular shell with a 3D surface for biological fixation, fabricated from Commercially Pure Titanium (CPTi). The shell is built upon the design features and clinical history of the existing Trident® Tritanium®, Trident® AD, and Trident® hemispherical acetabular (HA) shells. The device is designed with a roughened surface and high coefficient of friction to resist micromotion and promote initial fixation. The Tritanium® Acetabular Shell, intended for use in a cementless application, is available in sizes from 44 millimeter (mm) through 66 mm and is compatible with Trident® polyethylene insert and acetabular screws. This advanced technology is designed to address the need for improved initial and biological fixation. Data in support of these marketing claims will be collected in the Tritanium® Primary Acetabular Shell Study.
A prospective, post-market, multi-center design will be employed. Radiographs will be assessed by an independent reviewer.
Cases will be enrolled at 7 to 12 centers. The enrollment goal ranges from 20 to 34 cases implanted with the Tritanium® Acetabular Shell per center. The enrollment goal range is dependent upon the number of participating centers as well as the relative rates of enrollment of the two treatment groups. Although a range is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the overall enrollment goal or enrollment into one of the treatment groups is completed, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) approval. Non-compliance of a study center may result in termination of the center's participation in the study.
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 —（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 years or older at time of study device implantation.
- •C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •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 and rehabilitation.
排除标准
- •F. Patient has a Body Mass Index (BMI) ≥
- •G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- •H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •I. 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.
- •J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- •L. Patient has a known sensitivity to device materials.
- •M. Patient is a prisoner.
结局指标
主要结局
Absence of Acetabular Revision
时间窗: 5 years
To evaluate the success rate of cementless primary total hip replacement (THR) in hips implanted with the Tritanium® Acetabular Shell, as compared to the published results of similar acetabular components. Success will be defined as absence of acetabular shell revision for any reason at 5 years postoperative. It is expected that the survivorship of the Tritanium® Acetabular Shell group will be non-inferior to the survivorship reported in the literature for similar competitive devices.
次要结局
- Rates of Screw Fixation Usage in the Tritanium® Acetabular Shell(Intraoperative)
- Harris Hip Score(1, 3, and 5 years)
- Short Form- 12 (SF-12) Heath Survey Scores(1, 3, and 5 years)
- Lower Extremity Activity Scale (LEAS) Score(1, 3, and 5 years)
- EuroQol Five-Dimensional (EQ-5D)(1,2,3,4, and 5 years)
- Follow-Up Questionnaire(6, 7, 8, 9, and 10 years)
- Acetabular Shell Radiographic Stability(6 weeks, 1, 3, 5 years)