Triathlon Tritanium Knee Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 680
- 试验地点
- 20
- 主要终点
- Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System
研究概览
简要总结
The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.
详细描述
Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal 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 enrollment goal, 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) or Ethics Committee (EC) 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
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female age 18-75 years at time of study device implantation.
- •Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has a Body Mass Index (BMI) >
- •Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
- •Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient is diagnosed with lumbar radicular pain.
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
结局指标
主要结局
Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System
时间窗: 2 years
Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.
次要结局
- Compare 2011 Knee Society Score (KSS) Scores Between Both Groups(2 years)
- Implant Survivorship (Baseplate and Patella)(10 years)
- Compare Oxford Knee Score (OKS) Scores Between Both Groups(2 years)
- Compare Short Form-12 (SF-12) Scores Between Both Groups(2 years)