The UK ADAPTIS Study
Launched by NORTHUMBRIA HEALTHCARE NHS FOUNDATION TRUST · Apr 15, 2025
Trial Information
Current as of May 25, 2025
Recruiting
Keywords
ClinConnect Summary
The UK ADAPTIS Study is looking at a new type of ankle replacement surgery using a device called the INFINITY™ with ADAPTIS™ and EVERLAST™ technology. This surgery is designed for people with severely damaged ankle joints due to conditions like arthritis or those who have had previous ankle surgeries that didn't work. The goal of the study is to see how well this new ankle replacement works in terms of reducing pain and improving movement, so patients can get back to their daily activities with less discomfort.
To be eligible for this study, participants must be 21 years or older, have end-stage ankle arthritis, and be willing to follow up with doctors after the surgery. During the study, participants will receive the new ankle replacement and will be closely monitored through check-ups and questionnaires to see how they are doing after the procedure. This study is currently recruiting participants, and it's important for anyone considering joining to understand the potential benefits, as well as the commitment to follow-up visits and rehabilitation.
Gender
ALL
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
About Northumbria Healthcare Nhs Foundation Trust
Northumbria Healthcare NHS Foundation Trust is a leading healthcare provider in the North East of England, renowned for its commitment to delivering high-quality patient care and advancing medical research. As a prominent clinical trial sponsor, the Trust actively engages in innovative research initiatives aimed at improving health outcomes and enhancing treatment options across a range of medical disciplines. With a robust framework for clinical governance and a multidisciplinary team of experienced professionals, Northumbria Healthcare focuses on fostering collaborative partnerships to drive evidence-based practices and contribute to the broader scientific community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Newcastle, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported