A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 22
- 主要终点
- Range of Motion
研究概览
简要总结
The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.
详细描述
The Triathlon® Posteriorly Stabilized (PS) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol).
The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon® PS Total Knee System.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.
- •The subject requires a primary cemented total knee replacement.
- •The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- •The subject has intact collateral ligaments.
- •The subject has signed the IRB approved, study specific Informed Patient Consent Form.
- •The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •The subject has inflammatory arthritis.
- •The subject is morbidly obese, BMI >
- •The subject has a history of total or unicompartmental reconstruction of the affected joint.
- •The subject has had a high tibial osteotomy or femoral osteotomy.
- •The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
- •The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- •The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
- •The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
- •The subject has had a knee fusion at the affected joint.
- •The subject has an active or suspected latent infection in or about the knee joint.
- •The subject is a prisoner.
结局指标
主要结局
Range of Motion
时间窗: 2 years
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
次要结局
- Patient Outcome Knee Society Score(1,2 and 5 years)
- Patient Outcome SF-36(1,2,3,4 and 5 years)
- Patient Outcome Lower-Extremity Activity Scale(1,2,3,4 and 5 years)
- Patient Outcome WOMAC(5 years)
- Radiographic Outcome(1,2 and 5 years)