The UK ADAPTIS Study

NCT06941558 | Active Not Recruiting

• 1 other identifier: NHCT0494
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Total Ankle Arthroplasty; Total Ankle Replacement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Pain and Disability

  Up to 5 years post-op

• Pain and Disability

  Up to 5 years post-op

• Pain and Disability

  Up to 5 years post-op

Study Arms (1)

INFINITY™ with ADAPTIS™ and EVERLAST™

OTHER

INFINITY™ with ADAPTIS™ and EVERLAST™ technology with Poly Insert for patients requiring primary TAA/TAR.

Device: INFINITY™ with ADAPTIS™ and EVERLAST™

Interventions

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.

INFINITY™ with ADAPTIS™ and EVERLAST™

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead
• South Tees Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Northumbria Healthcare NHS Foundation Trust

Newcastle, NE29 8NH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 23, 2025
• Study Start: April 23, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)