Northumbria Healthcare NHS Foundation Trust
Newcastle, NE29 8NH, United Kingdom
NCT Number: NCT06941558
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.
This study is active but is not currently recruiting participants.
21 year and older
All sexes
Interventional
Not applicable
Newcastle, NE29 8NH, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 2 years
Device survivorship, assessed by tracking revision rates
Time frame: 2 years
Device survivorship, assessed by tracking re-operations
Time frame: 2 years
Device survivorship, assessed by adverse events
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.
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.
Time frame: Up to 5 years post-op
Pain and disability assessed using a specific health-related quality of life questionnaire (EQ5D-5L)
Northumbria Healthcare NHS Foundation Trust
Other
INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up
Acronym: UK ADAPTIS
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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