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Active, Not Recruiting

NCT Number: NCT06941558

The UK ADAPTIS 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. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria Healthcare NHS Foundation Trust

Newcastle, NE29 8NH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Device Survivorship

    Time frame: 2 years

    Device survivorship, assessed by tracking revision rates

  3. Device Survivorship

    Time frame: 2 years

    Device survivorship, assessed by tracking re-operations

  4. Device Survivorship

    Time frame: 2 years

    Device survivorship, assessed by adverse events

Secondary outcomes

  1. Pain and Disability

    Time frame: Up to 5 years post-op

    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.

  2. Pain and Disability

    Time frame: Up to 5 years post-op

    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.

  3. Pain and Disability

    Time frame: Up to 5 years post-op

    Pain and disability assessed using a specific health-related quality of life questionnaire (EQ5D-5L)

Sponsors and collaborators

Lead sponsor

Northumbria Healthcare NHS Foundation Trust

Other

Collaborators

  • South Tees Hospitals NHS Foundation Trust

Registry information

Official study title

INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up

Acronym: UK ADAPTIS

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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