UK ADAPTIS™ Study
Research type
Research Study
Full title
INFINITY™ with ADAPTIS™ and EVERLAST™ technology total ankle replacement follow-up
IRAS ID
338603
Contact name
David Townshend
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
The study is a prospective, multi-centre observational cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert total ankle system for patients requiring primary total ankle replacement/arthroplasty (TAR/TAA).
INFINITY™ ankle implants are already routinely used in NHS hospitals. The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a newer development of the INFINITY™ ankle implant, designed to attach to the bone better and to wear out more slowly. It aims to additionally reduce pain, restore alignment, and replace flexion and extension movement in the ankle, as well as offering a better bony integration of the metallic components. Patients in this study will be amongst the first to receive INFINITY™ with ADAPTIS™ and EVERLAST™ system as part of their routine care, so it is important we find out how the implant performs and how well patients are doing after surgery.
Patients will include: male or non-pregnant female over 21 years old with a diagnosis of end stage ankle arthritis and requiring primary TAA/TAR and is suitable/listed for surgery using the INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert total ankle system; are physically and mentally willing and able to comply with post-operative follow-ups and rehabilitation schedule; those that can provide written consent.
The patients will be monitored clinically by routine post-operative follow-up examinations, including radiographs, in line with new implants and patient reported outcome measures (PROMs). The Manchester Oxford Foot & Ankle Questionnaire (MOXFQ) and Ankle Osteoarthritis Scale (AOS) are specific measures to assess pain, function and social interaction related to the foot and ankle. EQ5D-5L is a standardised instrument for use as a measure of health outcome and quality of life.
The length of the patient follow-up schedule in this study is based on the previously published UK INFINITY™ Study (Townshend et al., 2021).
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0053
Date of REC Opinion
11 Mar 2024
REC opinion
Favourable Opinion