A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Oxford Knee Score (OKS)
研究概览
简要总结
Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).
详细描述
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 requires a primary Optetrak Logic Total Knee Arthroplasty
- •Patient is skeletally mature with no obvious mechanical defect
- •Patient is mentally capable of completing follow-up visits
- •Patient is 18 years of age or greater at time of surgery
- •Patient will be available for follow-up out to 2 years
- •Patient has consented to participate in the clinical study
排除标准
- •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
- •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
结局指标
主要结局
Oxford Knee Score (OKS)
时间窗: 24 Months
function, pain
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 24 Months
total score and subscales
Hospital for Special Surgery knee score (HSS)
时间窗: 24 Months
total score, pain, function
Knee Society Score (KSS)
时间窗: 24 Months
total score, pain, function
次要结局
未报告次要终点