Clinical trial NCT06941558: The UK ADAPTIS Study
Official title: INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Ankle Replacement
Total Ankle Arthroplasty
Lead sponsor: Northumbria Healthcare NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: South Tees Hospitals NHS Foundation Trust
First posted: 2025-04-23
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional Status
timeFrame: 2 years
measure: Device Survivorship
timeFrame: 2 years
measure: Device Survivorship
timeFrame: 2 years
measure: Device Survivorship
timeFrame: 2 years
Secondary outcomes:
measure: Pain and Disability
timeFrame: Up to 5 years post-op
measure: Pain and Disability
timeFrame: Up to 5 years post-op
measure: Pain and Disability
timeFrame: Up to 5 years post-op
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
Study officials:
References: