Creating a new questionnaire to evaluate emotional wellbeing after knee replacement surgery
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
This study is trying out a new questionnaire to see how knee replacement surgery affects people's emotional wellbeing and experiences after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Invibio Ltd Industry-sponsored |
| Locations | 1 site (Leeds) |
| Trial ID | NCT06585267 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing a new Patient Reported Outcome Measure (PROM) to assess patients' emotional wellbeing and perceptions following Total Knee Replacement (TKR) surgery for knee arthritis. Participants will complete the newly developed questionnaire alongside validated tools like the EQ-5D-5L and Oxford Knee Score to gather quantitative data. The study is observational and does not involve any medicinal products or medical devices, making it a low-risk project. The goal is to enhance understanding of patient experiences post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone a Total Knee Replacement surgery within the last 3 months.
Not a fit: Patients who have experienced complications requiring further hospital admission or revision surgery after their knee replacement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the emotional wellbeing of patients after knee replacement surgery, leading to improved patient care and support.
How similar studies have performed: Other studies have successfully utilized patient-reported outcome measures to assess surgical outcomes, indicating that this approach is both valid and beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Leeds
- Chapel Allerton Hospital — Leeds, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Professor Hemant Pandit — Leeds Teaching Hospitals NHS Trust
- Study coordinator: Karen Robson
- Email: karen.robson@invibio.com
- Phone: +44 7765220492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.