A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,588
- 试验地点
- 3
- 主要终点
- Knee Society Score
研究概览
简要总结
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
详细描述
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
- •Patient is skeletally mature
- •Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary
排除标准
- •Patient has a local or systemic infection
- •Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
- •Patient is pregnant
- •Patient has a mental or physical condition that may invalidate evaluation of the data - ---
- •Patient is a prisoner
- •Surgery is contraindicated according to the applicable product package insert
结局指标
主要结局
Knee Society Score
时间窗: annually through study completion, maximum of 10-years
(KSS) - validated outcome score
Hospital for Special Surgery Knee Score
时间窗: annually through study completion, maximum of 10-years
(HSS) - validated outcome score
Oxford Knee Score
时间窗: annually through study completion, maximum of 10-years
(OKS) - validated outcome score
次要结局
未报告次要终点