Not yet recruitingOBSERVATIONAL

Biological Link Between Anxiety and Outcomes Post Knee Arthroplasty

This study wants to find out if there's a biological reason why some patients who feel anxious or depressed before knee or hip replacement surgery might not recover as well. Researchers are looking at inflammation in the joint using small tissue, fluid, and blood samples collected during the operation and at routine appointments. They'll compare these findings with questionnaires filled out by patients about their pain, quality of life, and mood. The goal is to see if more inflammation might be linked to poorer recovery, or if emotional well-being simply affects how patients report their progress. This is an observational study, meaning it doesn't test new drugs or treatments.

At a glance

Status

Not yet recruiting

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Enrolment target

Start

01 Oct 2025

Estimated completion

01 Oct 2028

Total Knee Arthroplasty

What is this study about?

This study aims to understand why some people who feel anxious or depressed before having a knee or hip replacement operation might have a tougher recovery. Researchers think there might be a biological reason for this, specifically looking at whether there's more inflammation (swelling) inside the joint.

Imagine your body's natural healing response. Sometimes, if you're feeling stressed or low, it might affect how your body deals with inflammation. This study wants to see if patients with anxiety or depression have more inflammation in their joint tissue or blood, and if this extra inflammation plays a part in them reporting poorer outcomes after surgery. It's also possible that anxiety or depression simply makes people feel less satisfied with their recovery, even without a clear biological cause.

It's important to know that this study isn't testing any new medicines or treatments. It's an 'observational' study, which means the researchers are just watching and collecting information to better understand the links between mental well-being, inflammation, and recovery. All samples are collected as part of your normal care, using tissues that would usually be discarded.

Key takeaways

Looks at links between pre-surgery anxiety/depression and recovery.
Investigates if joint inflammation plays a role.
Uses blood and joint samples collected during routine care.
Requires questionnaires about your pain, mood, and quality of life.
No extra hospital visits needed; fits around your normal care.
Aims to improve understanding for future patients.

Who may be eligible?

To join this study, you need to be 18 years old or older and be planning to have a total knee or hip replacement at the Robert Jones and Agnes Hunt Orthopaedic Hospital. Your Body Mass Index (BMI) also needs to be less than 35.

There are some reasons why you might not be able to take part. For example, if you have rheumatoid arthritis or other similar inflammatory joint conditions, you won't be eligible. Also, if you're taking steroids, aspirin, or certain pain medications called COX inhibitors, you can't join. Finally, if you smoke or use vapes, you won't be able to participate in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a total knee or hip replacement at the specified hospital?
Is your Body Mass Index (BMI) below 35?
Do you NOT have rheumatoid arthritis or similar inflammatory joint diseases?
Are you NOT currently taking steroids, aspirin, or certain pain medicines (COX inhibitors)?
Do you NOT smoke or vape?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the research team will first send you some information about the study and a consent form by post before your standard pre-operative appointment. A researcher will then call to chat about the study and answer any questions you have. At your routine pre-operative clinic visit, a nurse will make sure you understand everything and get your written permission to join.

At this first visit, you'll fill out some questionnaires about your pain, how you feel day-to-day, and your mood. On the day of your surgery, a small amount of extra blood (about 20ml) will be collected when you're already having routine blood tests. Also, during your operation, while you're asleep, the surgeon will collect tiny samples of tissue and fluid from your joint that would normally be thrown away. These samples will be sent for analysis.

Three months after your surgery, at your routine check-up, you'll fill out the same questionnaires again and provide another small blood sample (about 15ml). Finally, six months after surgery, you'll complete the questionnaires from home using a special app on your phone or tablet. You won't need any extra hospital visits for this study, as everything is designed to fit in with your usual care. The total duration of your active involvement will be six months.

Potential risks and benefits

Taking part in this study means very little extra risk for you. The tissue samples are collected during your surgery, from material that would usually be discarded, so this doesn't add any extra procedures or risks during your operation. You'll have two extra blood samples taken; one on the day of surgery at the same time as your routine blood tests, and another at your 3-month check-up. The main risks with blood tests are minor discomfort or bruising where the needle goes in. There are no direct benefits to you as a participant from doing the study, but the information collected will help doctors better understand recovery after joint replacement surgery, potentially helping future patients. Remember, you can choose to leave the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Robert Jones and Agnes Hunt Orthopaedic Hospital
Verified postcode
Oswestry, United Kingdom

Common questions

What kind of samples will be collected?

Researchers will collect small amounts of blood, as well as joint fluid, tissue, and fat from your knee or hip during your surgery. The joint samples are normally thrown away.

Will I have extra appointments?

No, all study activities are planned around your usual appointments, so you won't need any extra visits to the hospital.

Will this study test a new drug?

No, this study is just observing and collecting information; it's not testing any new medicines or treatments.

How will my personal information be handled?

All your samples and information will be made anonymous, meaning your name won't be linked to the results.

What happens if I change my mind?

You can decide to stop taking part in the study at any time, and it won't affect your medical care.

How to find out more

Julie Steen

julie.steen@nhs.net +441691404418 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.