A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 254
- 试验地点
- 18
- 主要终点
- Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening
研究概览
简要总结
The purpose of this study was to evaluate the success rate of the Triathlon Tritanium Cone Augment with the Triathlon TS Total Knee System at 2 years postoperative, defined as absence of revision of the Femoral Cone Augment or Tibial Cone augment for aseptic loosening.
详细描述
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative. The total enrollment goal for the study is 145 cases have received the Triathlon TS Total Knee System with a Triathlon Tritanium Cone Augment. Additionally, between 40-50 cases (within the study population) will receive the Triathlon TS Total Knee System with a Triathlon Tritanium Central Femoral Cone Augment.
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
- •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, skeletally mature and age 18 years or older at time of study device implantation.
- •Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
- •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 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.
- •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.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient has a failed unicondylar knee prosthesis.
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
研究组 & 干预措施
Triathlon Tritanium Cone Augments
Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment.
干预措施: Triathlon Tritanium Cone Augments (Device)
结局指标
主要结局
Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening
时间窗: 2 year
次要结局
- Severity of end-of-stem pain.(2 year)
- Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.(intraoperative)
- Presence of end-of-stem pain in relation to the Triathlon Tritanium Cone Augments location.(2 year)
- Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.(intraoperative)
- Anderson Orthopaedic Research Institute (AORI) classification and Tibial Symmetric Cone Augment size.(intraoperative)