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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr David Townshend
+44 (0)1912934021
David.townshend@nhct.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Post-market surveillance study of the ADAPTIS Total Ankle Replacement with EVERLAST polyethylene insert
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Post-market surveillance study of the ADAPTIS Total Ankle Replacement with EVERLAST polyethylene insert

Not Recruiting

Open to: All Genders

Age: Adult

Edinburgh Bristol Sheffield Exeter Poole Stanmore Torquay Wigan North Shields Oswestry Nottingham

Medical Conditions

INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement/arthroplasty (TAR/TAA) across up to 10 UK NHS Hospital Trusts regularly performing TAA/TAR.

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.


An ankle replacement procedure consists of replacing the worn-out joint surfaces of the ankle with metal and plastic components that are shaped to allow continued movement of the ankle. There are several different types of ankle replacement available. All current ankle replacements have limited durability, and developing systems with improved durability is important. INFINITY™ ankle implants are already routinely used in NHS hospitals. The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the INFINITY™ ankle implant. This new implant has been designed to attach to the bone better and to wear out more slowly, potentially providing a better outcome for patients. This study is being conducted to find out how the INFINITY™ with ADAPTIS™ implant performs and how well participants are doing after surgery. Participants in this study will be among the first to receive INFINITY™ with ADAPTIS™ and EVERLAST™ system in the hospital.

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:

18 Apr 2024 27 Aug 2025

Before surgery: After consenting for the study, the research team will collect information from the participant's medical notes, including x-rays. The team will also contact the participant at either their appointment, via email or telephone to complete some questionnaires.

Surgery and hospital stay: A surgeon will perform the surgery using the INFINITY™ with ADAPTIS™ and EVERLAST™ Technology Total Ankle System. The care received in the hospital will be the same as standard care. The research team will collect information from medical notes about the surgery.

After surgery: After surgery, participants will be required to attend clinical appointments and receive additional x-rays as part of the enhanced follow-up process for up to 5 years.

• Outpatient appointments: First follow-up visit will be at 6 weeks post-surgery. Participants will be required to attend outpatient appointments and undergo x-rays at 6 months, 1 year, 2 years and 5 years post-operatively. Teams will collect information on any issues.

• Questionnaires: Participants will be asked to complete questionnaires at 6 months, 1 year, 2 years and 5 years post-operatively. These can be completed at a face-to-face appointment, over the telephone or via email.


Patients aged over 21 years who are on the waiting list for a total ankle replacement and their surgeon has made a separate clinical decision confirming that they are suitable to receive the INFINITY™ with ADAPTIS™ and EVERLAST™ Technology Total Ankle System for the total ankle replacement surgery.

You can take part if:



You may not be able to take part if:


1. Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.2. Any patients presenting with clinically relevant conditions prior to implantation that would contraindicate the implantation of a TAA/TAR.


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

  • NHS Lothian
    Waverley Gate 2-4 Waterloo Place
    Edinburgh
    EH1 3EG
  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Northern General Hospital
    Northern General Hospital NHS Trust C Floor, Huntsmnan Building Herries Road
    Sheffield
    S5 7AU
  • Royal Devon University Healthcare NHS Foundation Trust
    Royal Devon University NHS Ft Barrack Road
    Exeter
    EX2 5DW
  • Poole Hospital
    Longfleet Road
    Poole
    BH15 2JB
  • Royal National Orthopaedic Hospital
    Brockley Hill
    Stanmore
    HA7 4LP
  • Torbay Hospital
    Newton Road
    Torquay
    TQ2 7AA
  • Royal Albert Edward Infirmary
    Wigan Lane
    Wigan
    WN1 2NN
  • North Tyneside General Hospital
    Rake Lane
    North Shields
    NE29 8NH
  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
    Gobowen
    Oswestry
    SY10 7AG
  • NIHR Nottingham Biomedical Research Centre
    Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH

It is hoped that the INFINITY™ with ADAPTIS™ and EVERLAST™ Technology Total Ankle System will offer:
1. Bony integration of the metallic components
2. Reduced pain
3. Restored alignment
4. Replacement of flexion and extension movement in the ankle
1. Pain reduction
2. Increased function
3. Improved quality of life
This study may help us to better treat future patients who need total ankle replacement surgery and inform future research.
Any surgery carries potential risks, including the surgery as part of this study. The potential risks relating to a total ankle replacement in general include:
2. Infection
3. Deep venous thrombosis
4. Post-operative pain
5. Heterotopic ossification
6. Fracture of the prosthesis
7. Fracture of the bone
8. Loss of muscle force
9. Nerve and vessel injury
10. Wound healing problems
11. Implant failure
12. Medical complications
13. Death
The evidence from testing the INFINITY™ with ADAPTIS™ and EVERLAST™ Technology Total Ankle System tells us that the risks are unlikely to be higher than the alternative options.
For women, the surgeon must be aware if they become pregnant before/after their surgery, as there could be additional risks to them or their foetus. If they become pregnant after surgery, the study team will continue to keep them in the study and follow-up, however, they will not expose them to additional radiographs during maternity.
Participants will have an x-ray of the ankle taken before the surgery (within 12 months prior to surgery), and at 6 months, 1 year, 2 years and 5 years post-operatively. As a newer implant was chosen as part of a routine treatment, participants will be monitored more closely, and so it is possible they may get slightly more X-rays than if they didn’t take part, however, any difference in the schedule will be small.
X-rays use ionising radiation. Ionising radiation may cause cancer many years or decades after exposure. Everyone is at risk of developing cancer during their lifetime. 50% of the population is likely to develop one of the many forms of cancer at some stage during their lifetime. Taking part in this study will add only a very small chance of this happening.

Mr David Townshend
+44 (0)1912934021
David.townshend@nhct.nhs.uk



The study is sponsored by Northumbria Healthcare NHS Foundation Trust and funded by Stryker.



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Read full details for Trial ID: ISRCTN15076882

Or CPMS 61149

Last updated 09 September 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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