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RecruitingNAINTERVENTIONAL

A Randomised Control Trial Comparing Functional Outcomes for Navigated Kinematically Aligned TKR Versus Navigated Mechanically Aligned TKR

This study is looking at two types of total knee replacement (TKR) surgery. Both use computer navigation to help surgeons, but they have different ways of aligning the new knee joint. One is called 'kinematically aligned' and the other is 'mechanically aligned'. The main goal is to compare how well patients can use their knee, including how far they can bend and straighten it, after each type of surgery. This research aims to understand if one alignment method leads to better movement and overall comfort for people needing a knee replacement due to arthritis.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Hull University Teaching Hospitals NHS Trust
Enrolment target
100
Start
18 Feb 2018
Estimated completion
31 Dec 2026

What is this study about?

Imagine you need a new knee because of arthritis, which makes your knee hurt and stiff. When surgeons perform a total knee replacement, they have to carefully position the new knee parts inside your leg. This study is like a test to see which of two common methods for positioning the new knee works best for patients.

Both methods use special computer guidance, like a satnav for the surgeon, to help them be very accurate. However, one method tries to put the new knee in a way that’s unique to your natural leg shape (called 'kinematically aligned'), while the other aims for a more standard, straight alignment (called 'mechanically aligned'). Doctors want to find out if one way helps you bend and straighten your knee more easily and feel better overall after surgery.

By comparing these two approaches, doctors hope to learn which one leads to better comfort, movement, and long-term success for patients needing a new knee. This helps them improve total knee replacement surgery for everyone in the future.

Key takeaways

  • Compares two knee replacement methods for better outcomes.
  • Uses computer navigation for precise surgery.
  • Aims to improve patient comfort and knee movement.
  • Patients randomly assigned to one of two surgery types.
  • Takes place at Hull and East Yorkshire NHS hospitals.
  • Participation is voluntary and can be stopped any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 90 years old and have been diagnosed with a type of arthritis called degenerative osteoarthritis in your knee. You will be invited to take part if you are visiting one of the orthopaedic surgeons at Hull and East Yorkshire NHS hospitals for your knee problems.

There are some reasons why you wouldn't be able to join. For example, if your arthritis was caused by an injury (like a broken bone), if your knee is very bent or crooked (more than 20 degrees), or if you can't straighten your knee fully (more than 20 degrees bent). You also can't join if you've had other leg surgery recently, have certain nerve or muscle problems, or have another type of inflammatory arthritis.

Patients who have difficulty making decisions, children, or those involved in other research studies in the last six months also won't be able to take part. Researchers want to make sure the study only includes people where these specific knee replacement methods can be properly compared without other health issues complicating the results.

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.

  1. Are you between 18 and 90 years old?
  2. Do you have diagnosed degenerative osteoarthritis in your knee?
  3. Have you not had any other leg surgery in the last year?
  4. Are you able to provide consent and understand information clearly?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be one of about 130 patients. You would be seen at Hull Royal Infirmary or Castle Hill Hospitals. Your surgeon will randomly assign you to have one of the two types of knee replacement surgery – either the kinematically aligned or mechanically aligned method. You won't get to choose which one, as this helps make the study fair.

The surgery itself will be performed by one surgeon. After your operation, the research team will check in with you to see how your knee is recovering. They will measure how much you can move your knee and how well you are able to do your daily activities. These check-ups will help compare the two different surgery methods. The exact number and timing of follow-up visits aren't detailed here but will be fully explained if you are considering joining. You won't be paid for taking part in this study.

Potential risks and benefits

This study aims to find the best way to perform knee replacement surgery, potentially leading to better outcomes for future patients. While you might not directly benefit from being in a specific group, the information gained could improve care for everyone. As with any surgery, there are risks, and these will be explained thoroughly by your medical team; your involvement in the study doesn't change the standard care you receive. You are completely free to withdraw from the study at any time, for any reason, 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.
  • Hull University teaching hospitals
    Verified postcode
    Hull, United Kingdom· Recruiting

Common questions

What is a 'Total Knee Replacement' (TKR)?

It's an operation where a damaged knee joint is replaced with artificial parts, helping to relieve pain and improve movement.

What's the difference between the two surgery types?

Both are knee replacements, but they use slightly different ways to align the new knee joint inside your leg. One aims for a natural alignment, the other for a more standard, straight alignment.

Will I know which type of surgery I'm getting?

No, you will be randomly assigned to one of the two types to make the study fair. This is common in research studies.

Who will perform my surgery?

One surgeon will perform all the surgeries for the study, ensuring consistency.

Can I still decide not to join the study?

Yes, absolutely. You have plenty of time to decide and can change your mind at any point, even after agreeing.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Randomised Control Trial Comparing Functional Outcomes for…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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