Uncemented Tritanium TKR vs Cemented Triathlon TKR
We are comparing two different types of knee replacement surgery. Both surgeries replace a worn-out knee joint, but they fix the new joint in place differently. One uses cement, and the other doesn't (it's called uncemented). We want to understand if the uncemented method helps keep the bone around your new knee stronger compared to the cemented method. Losing bone strength around a knee replacement can sometimes lead to problems later on. This first part of the study is a small test run to make sure our research methods are good before we do a larger study. It focuses on people with knee osteoarthritis between 50 and 70 years old.
At a glance
What is this study about?
When you have your knee replaced, the new joint needs to be securely fixed to your existing bone. There are different ways to do this. One common way is using a special cement to hold the new joint in place. Another way, which is becoming more common, is an "uncemented" approach, where the new joint has a special surface that allows your bone to grow directly onto it, fixing it in place naturally.
Doctors have noticed that sometimes, after a knee replacement, the bone around the new joint can become a bit weaker. We don't fully understand why this happens, but one idea is that the cement used in some knee replacements might stop the bone from feeling the normal stresses and strains it needs to stay strong. Bone is a living tissue that needs to be used and loaded to maintain its density, much like muscles need exercise to stay strong.
Losing bone strength around your new knee could potentially lead to problems, such as the new joint becoming loose or even increasing the risk of a bone breaking around the replacement. This study wants to see if the uncemented knee replacement is better at maintaining bone strength compared to the cemented one. This first small study will help us work out the best way to do a bigger study later on.
Key takeaways
- Compares two knee replacement methods: cemented vs. uncemented.
- Aims to check bone strength around the new knee.
- This is a small initial study to test how it works.
- For individuals aged 50-70 with specific knee arthritis.
- Involves extra scans and questionnaires.
- You can stop participating at any time.
Who may be eligible?
To take part in this study, you would need to be having your first knee replacement at the RD+E Hospital, specifically for a type of arthritis called tricompartmental osteoarthritis. You'd also need to be between 50 and 70 years old when you have your surgery. It's really important that you're willing to come to all the appointments and complete any questionnaires involved in the study.
There are some reasons why you might not be able to join. For example, if your knee isn't suitable for the standard knee replacement parts being used in the study, or if you are pregnant. We also can't include people who have certain health conditions or are taking specific medications that might affect bone health, such as some treatments for bone thinning. If you've had other leg surgery recently or are expecting more in the next year (apart from the knee replacement), you won't be able to participate. Also, if you have a very high BMI (Body Mass Index) of 38 or more, or if there's any sign of infection in your knee, you unfortunately won't be suitable for this study.
Finally, it's essential that you can understand the study information and give your consent freely. If you have difficulties reading or understanding, or if there are other reasons that might make it hard for you to follow the study schedule, you might not be able to participate.
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.
- Am I having my first knee replacement at RD+E Hospital?
- Is my knee problem osteoarthritis affecting all three parts of my knee?
- Am I between 50 and 70 years old?
- Am I willing to come to all study appointments and fill out forms?
- Do I have any other major health issues or take medications for bone thinning?
- Is my BMI (Body Mass Index) less than 38?
What does participation involve?
If you decide to take part, you'll be giving your permission (consent) for the study. You would then undergo the chosen knee replacement surgery. Before and after your operation, you would have several check-ups and some special scans, called DEXA scans, to measure your bone density around the knee. You would also be asked to fill out some questionnaires about your knee and general health. The study involves a few visits over a period of time, with the exact schedule explained to you fully. The total duration of your involvement will be confirmed before you agree to take part.
Potential risks and benefits
Locations (1)
- Royal Devon and Exeter NHS Foundation Trust HospitalVerified postcodeExeter, United Kingdom
Common questions
What is the main goal of this study?
To see if uncemented knee replacements help keep bone around the new knee stronger compared to cemented ones.
What does 'uncemented' mean?
It means the new knee joint is designed to allow your own bone to grow onto it, holding it in place without glue.
Who can join this study?
People having their first knee replacement for arthritis at RD+E Hospital, aged 50-70.
Will I get extra scans if I join?
Yes, you will likely have extra bone density scans (DEXA scans) as part of the study.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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