A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 11
- 主要终点
- Active 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® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.
详细描述
The Triathlon® Cruciate Retaining (CR) 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 Cruciate Retaining (CR) Total Knee System as compared to the historical control.
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 between the ages of 21 and
- •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
- •Patient has inflammatory arthritis.
- •The subject is morbidly obese, BMI >
- •The subject has a history of total or unicompartmental reconstruction of the affected joint.
- •Patient has had a high tibial osteotomy or femoral osteotomy.
- •The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
- •The patient 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, which cannot provide adequate support and/or fixation to the prothesis.
- •The subject has had a knee fusion to the affected joint.
- •The subject has an active or suspected latent infection in or about the knee joint.
- •The subject is a prisoner.
研究组 & 干预措施
Triathlon® CR Total Knee System
Participants receive the Triathlon® CR Total Knee System
干预措施: Triathlon® CR Total Knee System (Device)
结局指标
主要结局
Active Range of Motion
时间窗: 2 Years
次要结局
- Implant Survivorship(10 years)
- Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)(1, 2, and 5 years)
- Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score(1, 2, and 5 years)
- Change in SF-36 Health Survey Over Time(preoperative, 1, 2, 3, 4, and 5 years)
- Change in Lower-Extremity Activity Scale (LEAS) Over Time(preoperative, 1, 2, 3, 4, and 5 years)
- Patient Outcome Long Term Follow-up Questionnaire Over Time(6, 7, 8, 9, and 10 years)
- Change in Knee Society Score (KSS) Over Time(preoperative, 1, 2, and 5 years)
- Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time(preoperative,1, 2, 3, 4 and 5 years)
- Patellar Subluxation, Dislocation and Fracture Rate(5 years)