A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Mean SF-36 Physical Component Score
研究概览
简要总结
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female, skeletally mature, 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 cemented 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 is already participating in the study for a contralateral total knee replacement.
- •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 any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.
- •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 severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
结局指标
主要结局
Mean SF-36 Physical Component Score
时间窗: pre-operative, 6 weeks, 1 year
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
次要结局
- Survivorship of Triathlon PSR Insert(1 Year)
- Range of Motion(PreOp, 6 weeks, 1 year)
- EuroQol-5 Dimension (EQ-5D)(PreOp, 6 week, 1 year)