An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 215
- 试验地点
- 9
- 主要终点
- Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
研究概览
简要总结
The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.
详细描述
The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use.
The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.
Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation.
The objectives of this study are to:
- Evaluate the effect of system component design on functional performance.
- Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
- Evaluate complications and the rates in which they occur.
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-
- •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, >60% over ideal body weight for frame and height.
- •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 a neuromuscular or neurosensory deficiency, which 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 steroids in excess of normal physiological requirements.
- •The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- •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.
- •The subject is pregnant.
研究组 & 干预措施
Scorpio® CR Total Knee System
Scorpio® CR Total Knee System Study Device
干预措施: Scorpio® CR Total Knee System (Device)
结局指标
主要结局
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
时间窗: 15 years
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Evaluate Complication Rate.
时间窗: 15 years
This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
次要结局
未报告次要终点