Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis Phase Four - Validation of Final Questionnaire This Phase is to Validate the Final Questionnaire in Terms of Reliability, Validity and Ability to Detect Change
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Invibio Ltd
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Validate final questionnaire
研究概览
简要总结
Development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis.
详细描述
Patients will complete the final developed questionnaire for quantitative analysis only (involves no administration of any medicinal products or medical devices) and is considered a low-risk project.
Patients will also be asked to complete the already validated EQ-5D-5L and Oxford Knee Score questionnaires at the same time as the final developed questionnaire following their Total Knee Replacement surgery.
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
- •Patients aged 18 years of age or older.
- •Patients who have undergone Total Knee Replacement surgery with a metal implant for the treatment of end-stage knee arthritis in the last 3 months.
- •Patients who have only undergone one Total Knee Replacement surgery on the index knee.
- •Patients who, in the opinion of the Investigator, are able to understand this project and co-operate with the requirements of participation.
- •Patients who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.
排除标准
- •Patients, who in the opinion of the Investigator, exhibit evidence of any condition or co-morbidity that would compromise their participation in the project.
- •Patients who are unable to understand and communicate fluently in English.
- •Patients who have experienced a complication following Total Knee Replacement surgery requiring a further hospital admission or revision surgery to the index knee.
研究组 & 干预措施
Main patient Group
Patients who have undergone Total Knee Replacement (TKR) Surgery
结局指标
主要结局
Validate final questionnaire
时间窗: From first post-op visit to 12month follow-up
Validation of final questionnaire
Validate final questionnaire
时间窗: From first post-op visit to 36month follow-up
Validation of final questionnaire
次要结局
未报告次要终点