Survival Study of the Genutech® Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of patients without revision surgery
研究概览
简要总结
Prospective cohort sudy of patients undergoing a Genutech® total knee arthroplasty
详细描述
A prospective cohort study will be performed collecting patient's data before and after the total knee arthroplasty surgical procedure at one, five and ten years. The main goal of this work is to prospectively study the results obtained with the implantation of the knee prosthesis currently used in the Orthopaedic Service of Sant Rafael Hospital of Barcelona (Genutech®). The main outcome of the study is the survival of the implant, that is, having no revision surgeries in the follow-up. The secondary objective is the clinical and radiological evaluation of the implants measured by outcome measueres: Oxford Knee Score (OKS), SF12 questionnaire and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. OKS and SF12 scores are higher with good results and lower with bad results. WOMAC expresses results the other way around.
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
- •Patients older than 18 years with knee osteoarthritis that had not responded to conservative treatment
- •capable of providing informed consent
- •patients who receive a Genutech® total knee prosthesis at the investigators' Institution.
排除标准
- •having received a prior total knee arthroplasty in the same joint
- •inability to provide informed consent
- •not willing to participate in the study
结局指标
主要结局
Number of patients without revision surgery
时间窗: 5 and 10 years
the main goal is to determine the implant survival, that is, having no revision during follow-up. The number of patients requiring revision will be compared to the total of patients included in the study.
次要结局
- Oxford Knee Score(one, 5 and 10 years)
- SF12 questionnaire(1, 5 and 10 years postoperatively)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire(One, 5 and 10 years)