Active not recruitingOBSERVATIONAL

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

This research project is creating a new set of questions to help us understand how people feel emotionally and what they think about their total knee replacement surgery for knee arthritis. We want to make sure the questionnaire helps doctors and researchers get a clearer picture of patients' experiences beyond just physical recovery. If you've had a total knee replacement within the last three months, you might be able to help. Taking part would simply involve completing this new questionnaire, along with two other standard questionnaires, to see how well they work and to gather important information about your experience with your knee replacement. This is a low-risk study focused on understanding patient perspectives through written responses.

At a glance

Status

Active not recruiting

Sponsor

Invibio Ltd

Enrolment target

167

Start

07 Oct 2024

Estimated completion

14 Apr 2026

Complete Questionnaires Following TKR Surgery

What is this study about?

Imagine you've had a total knee replacement because of arthritis. While doctors know a lot about how well the surgery fixes the physical problems, it's also important to understand how people *feel* about their surgery and how it affects their emotional well-being. This project aims to create a new questionnaire specifically for this purpose.

This new questionnaire will help doctors and healthcare professionals understand your emotional recovery and your overall views on your knee replacement. By gathering this kind of information directly from patients, we can get a much clearer picture of what really matters to people undergoing this surgery. This will hopefully lead to better care and support for future patients.

To make sure this new questionnaire is good and works well, we need people who have had knee replacement surgery to complete it. You will also fill out two other well-known questionnaires that ask about your quality of life and knee pain. Your answers will help us develop a valuable tool that captures a full picture of the patient experience.

Key takeaways

New questionnaire about emotional well-being after knee replacement.
Only involves completing forms, no medication or extra appointments.
Helps improve care and understanding for future patients.
Participation is entirely voluntary and low-risk.
Must have had knee replacement in the last 3 months, age 18+.

Who may be eligible?

You might be able to take part in this project if you are 18 years old or older and have had a total knee replacement for severe arthritis in the last three months. It's important that this was your first knee replacement on that specific knee, and that you haven't had any major problems since the surgery that required you to go back to hospital or have another operation on the same knee.

We need people who can understand what the project is about and are happy to give their written permission to take part. You should also be able to understand and speak English well enough to complete the questionnaires.

Unfortunately, you wouldn't be able to join if your doctor thinks you have other health conditions that would make it difficult for you to take part, or if you've had complications with your knee replacement that needed another hospital stay or surgery.

Quick self-check

Are you 18 years old or older?
Did you have a total knee replacement for arthritis within the last 3 months?
Was this your first knee replacement on that specific knee?
Have you not had any major complications needing another hospital stay or surgery on that knee?
Can you understand and speak English well enough to fill out forms?
Are you able to agree to take part in writing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, your involvement will be very straightforward. You won't need to take any new medicines or use any special medical devices. Instead, you'll be asked to complete a set of questionnaires. This typically involves filling out the new questionnaire we are developing, along with two other standard questionnaires that ask about your health and knee function.

You would complete these questionnaires in one session, usually following your total knee replacement surgery. There are no follow-up visits or long-term commitments required for this study. The total time commitment would be limited to the time it takes to fill out the forms.

Potential risks and benefits

The potential benefit of taking part is that your input will directly help create a new tool to better understand the emotional well-being and experiences of people undergoing knee replacement surgery. This could lead to improved care for future patients. There are no known physical risks involved in this study, as it only involves completing questionnaires. There is a small chance you might find some questions sensitive, but you are free to skip any questions you don't wish to answer. Your participation is completely voluntary, and you can change your mind and withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (1)

Chapel Allerton Hospital
Leeds, United Kingdom

Common questions

What is a 'Patient Reported Outcome Measure' (PROM)?

It's a questionnaire that asks you directly about your health, how you feel, and what you can do, from your own point of view.

Will I have to take any new medication?

No, this study only involves completing questionnaires. You won’t be given any new medicines or devices.

How long will I need to take part for?

You will only need to complete the questionnaires in one session. There are no ongoing commitments or follow-up visits.

Will my answers be kept private?

Yes, all your responses will be handled confidentially and your personal information will be protected.

What if I change my mind after joining?

You are free to withdraw from the study at any time, for any reason, and it will not affect your medical care.