RecruitingPHASE1, PHASE2INTERVENTIONAL

COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

This study, called COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty, is looking into whether a single steroid injection in the knee that isn't being operated on can help patients undergoing total knee replacement (TKA). Many people who need one knee replaced also have arthritis in the other knee, which can cause pain and make recovery harder. Researchers want to see if this injection can reduce pain and improve how well people can move after their surgery. It's a pilot study, meaning it's an initial investigation to see if this approach is promising. Patients will be randomly given either the steroid injection or a 'dummy' treatment, and neither they, their doctors, nor the researchers will know who got what.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Unity Health Toronto

Enrolment target

Start

24 Jan 2025

Estimated completion

30 Jul 2027

Total Knee Anthroplasty Osteoarthritis(Primary)Osteoarthritis (OA) of the Knee Bilateral Knee Osteoarthritis

What is this study about?

When you have severe arthritis in one knee and need a total knee replacement (TKA), it's quite common to also have some arthritis in the other knee that isn't being operated on. This can sometimes make your recovery from surgery more challenging. You might find yourself relying more on the unoperated knee, which can lead to it becoming sore or painful, making it harder to get back to full activities.

This study is exploring a way to potentially help with this issue. It's looking at what happens when patients having a knee replacement get a steroid injection into their *other* knee – the one that isn't being operated on. Steroid injections are already a common treatment for painful, arthritic joints as they can help reduce swelling and pain. The researchers hope that by giving this injection around the time of surgery, it might help lessen pain in that unoperated knee and improve your overall recovery and how well you can move.

The main goal of this particular study is to see if this injection is effective. They will also be looking closely at how it affects pain levels and how well patients can move and do daily activities after their knee replacement surgery. It's important to remember this is a "pilot study," which means it's an early investigation to see if this idea is a good one to explore further.

Key takeaways

This study explores a steroid injection in the *unoperated* knee during knee replacement surgery.
The goal is to reduce pain in the other knee and improve overall recovery.
It's a pilot study to see if this treatment is effective and worthwhile.
You will be randomly assigned to receive either the steroid or a 'dummy' injection.
Neither you nor your doctors will know which injection you received until the study ends.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and scheduled for your first-ever total knee replacement on one knee because of primary osteoarthritis – the most common type of arthritis when the cartilage wears away.

It's important that your other knee (the one not being replaced) also has some pain and signs of arthritis, with a pain score of more than 4 out of 10. You shouldn't have had any steroid or similar injections in that knee within the last year, and you shouldn't be planning to have surgery on that knee within the next six months. You also can't have any current infections or previous severe injuries, such as a broken bone or ligament damage, in that other knee. You must also be able to understand English and provide your agreement to take part.

People would not be able to join if their arthritis is due to other conditions like inflammation or a past injury. You also can't participate if you have memory problems (like dementia), have had a previous knee replacement on either knee, or have active infections or conditions that would make knee replacement surgery unsafe for you.

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 or older?
Are you having a total knee replacement for primary osteoarthritis on *one* knee?
Do you have pain in your *other* knee (the one not being operated on), scoring more than 4 out of 10?
Have you *not* had any steroid or similar injections in that other knee in the last year?
Are you able to speak and understand English?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the steroid injection or a 'dummy' injection (which looks the same but doesn't contain the steroid) in your unoperated knee around the time of your knee replacement surgery. Neither you, your doctor, nor the research team will know which injection you received during the study period.

Beyond your standard knee replacement care, additional participation would involve attending follow-up appointments where your pain levels and how well you can move your knee will be assessed. This will likely involve answering questionnaires and possibly some physical tests to measure your knee function. The total duration of your involvement in the study would span several months to track your recovery and the effects of the injection.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as a reduction in pain in your unoperated knee, which might improve your recovery after knee replacement surgery. However, there's no guarantee you will personally benefit. As with any medical procedure, there are potential risks, though steroid injections are common and generally safe. These could include temporary pain or swelling at the injection site, or, very rarely, infection. You will be fully informed of all known risks before deciding to join. Remember, taking part in this study is entirely voluntary, and you have the right to withdraw at any time without it affecting your medical care.

Locations (1)

St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'pilot study'?

A pilot study is a small, early investigation to see if a new treatment or idea is promising enough to be studied in a larger trial in the future.

What is an 'intra-articular corticosteroid injection'?

It's a shot of steroid medicine given directly into a joint (in this case, your knee) to help reduce pain and swelling caused by arthritis.

Will I know if I got the steroid or the dummy injection?

No, this is a 'triple-blinded' study, meaning neither you, your doctors, nor the research team will know which injection you received until after the study is over.

What is 'contralateral' mean?

In this study, 'contralateral' simply means the opposite knee – the one that is not having surgery.

Will this injection affect my knee replacement surgery?

The injection is given to your *other* knee, not the one being replaced, so it is not expected to interfere with your knee replacement surgery itself.

How to find out more

Cassandra Tardif-Theriault, BKin

cassandra.tardif-theriault@unityhealth.to 416-864-6060 Official trial record

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