Total Ankle ReplacementUK ADAPTISNCT06941558
The UK ADAPTIS Study
A study testing INFINITY™ with ADAPTIS™ and EVERLAST™ in people with Total Ankle Replacement and Total Ankle Arthroplasty, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Total Ankle Replacement, Total Ankle Arthroplasty
- What is being tested?
- INFINITY™ with ADAPTIS™ and EVERLAST™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2024to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female over the age of 21 years with a diagnosis of end stage ankle arthritis and requiring primary TAA/TAR and is suitable for the use of the ADAPTIS TAA/TAR
- Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
- Patient can understand and provide written consent.
Who cannot join
- Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.
- Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria Healthcare NHS Foundation Trust
Newcastle, NE29 8NH
About this study
Official title: INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up
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. 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, designed to attach to the bone better and to wear out more slowly.
The purpose of the UK ADAPTIS™ Study is to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement (TAR) or arthroplasty (TAA) and EVERLAST™ Poly Insert that modernises and streamlines Stryker's TAA/TAR portfolio.
Read more
UK ADAPTIS is a prospective multi-centre cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement (TAR) i.e. Total Ankle Arthroplasty (TAA).
Patients meeting the criteria for the study will be asked to enrol by providing written informed consent.
The patients will be monitored clinically by post-operative follow-up examinations and Patient reported outcome measures (PROMs) (Manchester Oxford Foot \& Ankle Questionnaire (MOXFQ), Ankle Osteoarthritis Scale (AOS), EQ5D-5L).
Intended use:
It is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing flexion and extension movement in the ankle joint.
Indications for use:
- Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
- Patients with a failed previous ankle surgery.
- Conditions
- Total Ankle Replacement, Total Ankle Arthroplasty
- Being tested
- INFINITY™ with ADAPTIS™ and EVERLAST™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFINITY™ with ADAPTIS™ and EVERLAST™Device
The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the Infinity ankle implant, designed to attach to the bone better and to wear out more slowly.
| Study group | Role | What they receive |
|---|---|---|
| INFINITY™ with ADAPTIS™ and EVERLAST™ | Other | INFINITY™ with ADAPTIS™ and EVERLAST™ technology with Poly Insert for patients requiring primary TAA/TAR. Receives: Device: INFINITY™ with ADAPTIS™ and EVERLAST™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Status
Functional status using MOXFQ (Manchester-Oxford Foot Questionnaire). The MOXFQ is scored on a 0-100 scale, where higher scores indicate more severe problems.
Measured: 2 years
Device Survivorship
Device survivorship, assessed by tracking revision rates
Measured: 2 years
Device Survivorship
Device survivorship, assessed by tracking re-operations
Measured: 2 years
Device Survivorship
Device survivorship, assessed by adverse events
Measured: 2 years
Secondary outcomes (3)
Pain and Disability
Pain and disability assessed using AOS (Ankle Osteoarthritis Scale) questionnaire. A higher score on the AOS reflects greater pain, functional limitations, and a generally poorer overall ankle-related health status.
Measured: Up to 5 years post-op
Pain and Disability
Pain and disability assessed using MOXFQ (Manchester-Oxford Foot Questionnaire). The MOXFQ is scored on a 0-100 scale, where higher scores indicate more severe problems.
Measured: Up to 5 years post-op
Pain and Disability
Pain and disability assessed using a specific health-related quality of life questionnaire (EQ5D-5L)
Measured: Up to 5 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start23 Apr 2024
- Primary completionSep 2027 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Ankle ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941558
- Sponsor's protocol ID
- NHCT0494
- Acronym
- UK ADAPTIS
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that a publication of the anonymous study results will be compiled and submitted to a peer-reviewed journal. The CI of the study will have the responsibility of being primary author of such publications. The study will be registered in the ISRCTN Trial Register and/or in clinicaltrials.gov by the CI.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up
- ClinicalTrials.gov ID
- NCT06941558
- Acronym / sponsor ID
- UK ADAPTIS / NHCT0494
- Conditions
- Total Ankle Replacement, Total Ankle Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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, designed to attach to the bone better and to wear out more slowly.
The purpose of the UK ADAPTIS™ Study is to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement (TAR) or arthroplasty (TAA) and EVERLAST™ Poly Insert that modernises and streamlines Stryker's TAA/TAR portfolio.
UK ADAPTIS is a prospective multi-centre cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement (TAR) i.e. Total Ankle Arthroplasty (TAA).
Patients meeting the criteria for the study will be asked to enrol by providing written informed consent.
The patients will be monitored clinically by post-operative follow-up examinations and Patient reported outcome measures (PROMs) (Manchester Oxford Foot \& Ankle Questionnaire (MOXFQ), Ankle Osteoarthritis Scale (AOS), EQ5D-5L).
Intended use:
It is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing flexion and extension movement in the ankle joint.
Indications for use:
- Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
- Patients with a failed previous ankle surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INFINITY™ with ADAPTIS™ and EVERLAST™ | Other | Device: INFINITY™ with ADAPTIS™ and EVERLAST™INFINITY™ with ADAPTIS™ and EVERLAST™ technology with Poly Insert for patients requiring primary TAA/TAR. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant female over the age of 21 years with a diagnosis of end stage ankle arthritis and requiring primary TAA/TAR and is suitable for the use of the ADAPTIS TAA/TAR
- Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
- Patient can understand and provide written consent.
Key exclusion criteria (2 listed)
- Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.
- Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFINITY™ with ADAPTIS™ and EVERLAST™The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the Infinity ankle implant, designed to attach to the bone better and to wear out more slowly. | Device | INFINITY™ with ADAPTIS™ and EVERLAST™ |
Primary outcome
Functional Status
Time frame: 2 years
Functional status using MOXFQ (Manchester-Oxford Foot Questionnaire). The MOXFQ is scored on a 0-100 scale, where higher scores indicate more severe problems.
Device Survivorship
Time frame: 2 years
Device survivorship, assessed by tracking revision rates
Device Survivorship
Time frame: 2 years
Device survivorship, assessed by tracking re-operations
Device Survivorship
Time frame: 2 years
Device survivorship, assessed by adverse events
3 secondary outcomes
Pain and Disability
Time frame: Up to 5 years post-op
Pain and Disability
Time frame: Up to 5 years post-op
Pain and Disability
Time frame: Up to 5 years post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. It is anticipated that a publication of the anonymous study results will be compiled and submitted to a peer-reviewed journal. The CI of the study will have the responsibility of being primary author of such publications. The study will be registered in the ISRCTN Trial Register and/or in clinicaltrials.gov by the CI.
Related trials for Total Ankle Replacement
Not yet recruitingPhase 2
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Ankle Arthritis, Wound Complication
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
Active, not recruitingObservational study
INFINITY™ With ADAPTIS™ Technology Study
Arthritis, Rheumatoid
RecruitingObservational study
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
Post Traumatic Arthritis, Osteoarthritis
Active, not recruitingObservational study
Survival, Clinical and Radiological Outcomes of Total Ankle Arthroplasty With Lateral Transfibular Approach With a Minimum 10 Years Follow up
Total Ankle Arthroplasty Surviviorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFINITY™ with ADAPTIS™ and EVERLAST™ in people with Total Ankle Replacement and Total Ankle Arthroplasty, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.