The UK ADAPTIS Study (UK ADAPTIS)

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Total Ankle Arthroplasty; Total Ankle Replacement
• Intervention / Treatment: Device: INFINITY™ with ADAPTIS™ and EVERLAST™

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle, United Kingdom, NE29 8NH
    • Northumbria Healthcare NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
3. Patient can understand and provide written consent.

Exclusion Criteria:

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 implantation of a TAA/TAR

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: INFINITY™ with ADAPTIS™ and EVERLAST™; INFINITY™ with ADAPTIS™ and EVERLAST™ technology with Poly Insert for patients requiring primary TAA/TAR.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
Device Survivorship	Device survivorship, assessed by tracking revision rates	2 years
Device Survivorship	Device survivorship, assessed by tracking re-operations	2 years
Device Survivorship	Device survivorship, assessed by adverse events	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 5 years post-op
Pain and Disability	Pain and disability assessed using a specific health-related quality of life questionnaire (EQ5D-5L)	Up to 5 years post-op

Collaborators and Investigators

• Sponsor: Northumbria Healthcare NHS Foundation Trust
• Collaborators: South Tees Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NHCT0494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No