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Mr Andrew Metcalfe
+44 (0)2476150925
RACER@warwick.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A comparison of standard versus robotic total knee replacement
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A comparison of standard versus robotic total knee replacement

Not Recruiting

Open to: All Genders

Age: Adult

Stanmore Edinburgh Coventry Birmingham Glasgow Newcastle upon Tyne Exeter Portsmouth

Medical Conditions

Osteoarthritis of the knee with pain, disability and changes on standard of care clinical images (x-rays or MRI according to normal clinical practice) that, in the opinion of the treating clinician, warrants total knee replacement (TKR)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Knee arthritis is a painful condition which can limit people’s activities. When knee arthritis is very bad, it can be treated with a knee replacement. These operations are often very successful at reducing pain and improving the amount of activity someone can do. They can be painful in the few weeks after the operation, and many people still have some knee symptoms, even some time after surgery.
Knee replacements have for many years been put in by surgeons using their experience and skill, with a standard set of instruments. However, some surgeons have started using a robotic arm to help them perform a knee replacement. The robotic arm is held by the surgeon during the operation and the surgeon always remains in control. The robot helps move the instruments into the correct position by sensing the position of the leg.
Those who believe that standard instruments are better think that the operation is quicker and simpler without the robot. They argue that they can make decisions and cut the bone with the same amount of precision and without the added expense of a robot. Whereas those who believe the robot is better think it makes them more precise, and that they can get a better result using the guidance provided by the robot.
No one yet knows if using the robot to help perform a knee replacement is any better or worse than performing a knee replacement with standard instruments. Therefore, this study will look at which operation is best at improving the way the knee feels after surgery. The study will also find out which operation results in less pain in the first few days after surgery, and which gives better quality of life in the long-term. The researchers will also study whether the use of the robot is worth the additional cost.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Nov 2020 05 Feb 2024

Publications

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37295832/ (added 12/06/2023)

Participants will be randomly allocated (by an online system) to have a knee replacement performed using either standard instruments or the robotic system. This will be done on the day of surgery. The surgeon will not be able to influence this decision.
Before the operation, every participant will have a CT scan of their knee to make a plan to best fit the knee replacement. A short scan of the hip and ankle will also be performed. As part of the study, a short CT scan of the knee and x-ray of the whole leg will also be undertaken 3 months after the operation. All other x-rays will be part of normal care.
For knee replacement with standard instruments, the surgeon will use their normal approach to perform a knee replacement and will be allowed to make whatever adjustments they think they need to get the best result for each participant. They will perform this using their usual instruments, as they would for any standard knee replacement, using the experience and skill they have built up in their clinical practice.
For knee replacement using the MAKO robotic system, the robotic system being tested is the Stryker MAKO system. This is the most widely used robotic knee replacement system at present. It has been used many thousands of times, in the UK and abroad, and it is safe. It has a CE mark and is licenced for use in the UK. The surgeon starts the operation and inserts some pins into the bone, at the top of the shin, often through two small (1 cm) incisions. The pins are used to show the computer where the bones are. The surgeon then performs the operation as usual, but instead of using their normal instruments, they use a robot to guide where they cut the bone, making whatever adjustments they think they need to get the best result. They will then insert the knee implants with cement in the normal way.
Participants having the standard operation will also have these two additional 1 cm incisions (even though they will not be used). This is to ensure that people in the study do not know which group they are in. These are very low risk and will not affect recovery.
On the day after the operation, and for the following 2 days, a member of staff will ask each participant about their knee pain. Each participant will also be given a discharge booklet (including advice and exercises) which explains what to do after the operation. If the surgical or physiotherapy team think extra physiotherapy is required, this will be organised.
Questionnaires that are used to assess joint awareness, pain, levels of activity, quality of life and satisfaction with the operation will be sent to participants at 6 weeks, 3, 6 and 12 months after surgery. The researchers will also send follow-up questionnaires 2, 5 and 10 years after the operation.


People with knee osteoarthritis who are due to undergo total knee replacement

You can take part if:



You may not be able to take part if:


1. Osteoarthritis secondary to inflammatory arthropathy or intra-articular fracture as determined by the treating clinician2. Revision surgery or need for complex implants, or any other implant than a standard Triathlon total knee replacement (TKR), as determined by the treating clinician. This includes nickel-free implants as well as those that require a long stem, augments, or custom made devices3. Age <18 years4. Unfit for TKR, or surgery is otherwise contraindicated (for example, concurrent infection)5. Previous randomisation in the present trial (i.e. other knee)6. Unable to take part in trial processes, including prisoners or people unable to communicate or complete questionnaires in English, or people unable to give informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal National Orthopaedic Hospital
    Brockley Hill
    Stanmore
    HA7 4LP
  • Royal Infirmary of Edinburgh
    51 Little France Crescent
    Edinburgh
    EH16 4SA
  • University Hospitals Coventry and Warwickshire
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • Royal Orthopaedic Hospital
    The Woodlands Bristol Road South
    Birmingham
    B31 2AP
  • Glasgow Royal Infirmary
    84, Castle Street
    Glasgow
    G4 0SF
  • The Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Royal Devon and Exeter NHS Foundation Trust
    Barrack Road
    Exeter
    EX2 5DW
  • Portsmouth Hospitals NHS Trust
    Southwick Hill Road
    Portsmouth
    PO6 3LY

It is not known which type of knee replacement provides the best outcome for patients both physically and in terms of wellbeing. Nor is it known whether the robot is worth the additional cost. By taking part in the trial, participants are helping to decide about the best treatment for people in the future.
There are general risks with any operation. When having a knee replacement, it is normal to get some early pain, swelling, bruising and some drowsiness or sickness from painkillers. Numbness over the knee and some stiffness are also normal. Risks of having a knee replacement include continued or worse pain, infection, wound problems, stiffness, need for further surgery including redoing the knee replacement, blood clots in the leg or lung, death, or injury to structures around the knee such as nerves or vessels. The additional risk of taking part in the study is very small. The pins in the bone used by the robot could cause a fracture of the bone, but this is thought to be rare (less than one in every 1,000 cases). The radiation dose from the scans have also been calculated and are very low risk.

Mr Andrew Metcalfe
+44 (0)2476150925
RACER@warwick.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University Hospitals Coventry and Warwickshire NHS Trust; University of Warwick and funded by National Institute for Health Research.




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Read full details for Trial ID: ISRCTN27624068

Or CPMS 45432

Last updated 12 February 2024

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