A Multicenter Prospective Cohort Study on Persona Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 4
- 主要终点
- Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system
研究概览
简要总结
In this project the investigators wish to:
Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.
This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.
Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively.
After the 2 year follow-up visit the patients recruited in the Scandinavian sites will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively. Since France does not have a national registry, the French site will also perform 5 year follow-up visits.
详细描述
The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations.
The enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed.
Surgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant.
Participants will receive standard pain treatment and rehabilitation until discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
排除标准
- •Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
- •Patients that meet any contraindications listed in the Instruction for Use
结局指标
主要结局
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system
时间窗: 2 years
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system as measured by Oxford knee score (OKS); a 12-item patient-reported Patient Reported Outcomes specifically designed and developed to assess function and pain after total knee replacement surgery. Score ranging from 0 (most severe symptoms/problems) to 48 (least severe).
次要结局
- Evaluate patient reported physical activity level following primary total knee replacement using Persona Total Knee system. An 8-item patient-reported outcome. Score ranging from 0 (most severe symptoms/problems) to 32 (least severe).(2 years)
- Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system(2 years)
- Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system(10 years)
- Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system(2 years)
- Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system(2 years)
- Evaluate intraoperative and postoperative complications(10 years)
- Evaluate implant positioning following primary total knee replacement using Persona Total Knee system(2 years)