Active not recruitingNAINTERVENTIONAL

Traditional Versus Alternative Alignment in TKR

Many people are unhappy with their total knee replacement (TKR) outcomes. This study explores if changing how knee implants are positioned can help. Traditionally, surgeons aim for a perfectly straight leg, which might strain tissues for some. A newer, 'alternative' method aims to match the patient's natural leg shape. Early signs suggest this alternative approach might improve how the knee works in the short term, without reducing satisfaction. This research will compare both methods using a specific knee replacement in Exeter. They will look at patient satisfaction, muscle strength, flexibility, scans, and how long the new knee lasts to see if the alternative method truly makes a difference to patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Enrolment target

126

Start

23 Oct 2018

Estimated completion

31 Dec 2025

Osteo Arthritis Knee

What is this study about?

If you're considering or have had a total knee replacement (TKR) for knee arthritis, you might be interested in this study. Up to 2 in 10 people aren't fully happy with their TKR results, even with various surgical improvements. This research focuses on how the new knee joint is aligned in your leg during surgery, as this might be a key factor in how your knee feels afterward.

Traditionally, when surgeons put in a new knee, they aim to make your leg perfectly straight, especially when looking at it from the front. This is done to balance the pressure evenly inside your joint. However, for some people, whose natural leg shape isn't perfectly straight, this traditional alignment might significantly change their leg's natural shape. This change could potentially put stress on the soft tissues around the new knee, possibly contributing to dissatisfaction after the operation.

Some surgeons are now trying a different approach, called 'alternative alignment'. Instead of aiming for a perfectly straight leg, they try to position the new knee joint to match your own body's natural leg shape more closely. Early studies on this alternative method haven't shown any reduction in patient satisfaction, and there are promising signs that it might even lead to better knee movement and function in the short term. This study will compare both the traditional and alternative alignment methods using a specific knee replacement (the Triathlon) to understand if this newer approach can lead to better outcomes for patients.

Key takeaways

The study compares two ways to align new knee joints during surgery.
It aims to see if an 'alternative' alignment improves patient results.
Participation involves regular check-ups and questionnaires for 8 years.
You won't know which alignment method you receive.
The study seeks to improve satisfaction for people undergoing knee replacement surgery.

Who may be eligible?

This study is looking for volunteers who are having their first total knee replacement at the RD+E Hospital. You need to be at least 60 years old and your body mass index (BMI) needs to be under 40. You should also be prepared to attend all appointments, rehabilitation sessions, and fill out questionnaires as requested by the study team.

There are also some specific requirements about your knee itself. For example, your knee shouldn't be too bent before surgery, or have a severe 'bow-legged' shape. If you have other health conditions that might interfere with your recovery or your ability to participate in the study, like certain psychological disorders or substance abuse, you might not be suitable. Also, if you’ve had other leg surgeries recently, are pregnant, or are a prisoner, you won't be able to join.

The research team will carefully check all these points to make sure the study is right for you and that you meet all the necessary criteria to ensure your safety and the quality of the research.

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 having your first total knee replacement at RD+E Hospital?
Are you 60 years old or older?
Is your BMI (Body Mass Index) less than 40?
Are you able to attend all study appointments and complete questionnaires?
Do you have knee arthritis (not an inflammatory type)?
Do you have a fixed knee bend of less than 15 degrees and a 'bow-legged' shape of less than 20 degrees?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to receive either the traditional or alternative alignment method during your total knee replacement. You won't know which method you receive. The study will involve regular check-ups and assessments before your surgery and for the following 8 years. You'll be asked to complete questionnaires about your knee and general health, and the research team will measure your muscle strength and flexibility. X-rays and special CT scans will also be used to check the position of your new knee. Throughout this period, you'll also undergo rehabilitation as you normally would after a knee replacement, and the study team will monitor your progress closely.

Potential risks and benefits

Participating in this study means you could potentially benefit from receiving a surgical technique that might lead to better knee function or satisfaction, although this is what the study aims to find out. There are no known additional risks beyond those typically associated with total knee replacement surgery. As with any surgery, risks include infection, bleeding, or issues with recovery, which will be carefully monitored. You are 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.

Royal Devon and Exeter Hospital
Verified postcode
Exeter, United Kingdom

Common questions

What is 'alignment' in knee replacement?

Alignment refers to how your new knee joint is positioned in your leg during surgery to ensure it works correctly and balances pressures.

What's the difference between 'traditional' and 'alternative' alignment?

Traditional aims for a perfectly straight leg. Alternative aims to match your natural leg shape more closely, rather than forcing it straight.

Will I know which method I receive?

No, you will be assigned to one method by chance, and neither you nor your surgeon will know which you received to keep the study fair.

How long will I be involved in the study?

Your involvement in the study will last for 8 years, with check-ups and assessments over this period.

What are the main things the researchers are looking for?

They want to see if the alternative alignment method improves how well your knee works and if you are more satisfied with the results compared to the traditional method.