Assessing a new ankle replacement system for arthritis patients
INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up
This study is testing a new ankle replacement system to see if it works better for people with severe ankle arthritis than current options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Northumbria Healthcare NHS Foundation Trust Academic / other |
| Locations | 1 site (Newcastle) |
| Trial ID | NCT06941558 on ClinicalTrials.gov |
What this trial studies
The UK ADAPTIS Study evaluates the performance and functionality of the INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system in patients with end-stage ankle arthritis. This interventional study involves a multi-centre cohort of patients requiring primary total ankle arthroplasty or replacement. The goal is to determine how well this new technology performs compared to existing options, focusing on its attachment to bone and durability. Participants will undergo the ankle replacement procedure and will be monitored for outcomes related to their recovery and joint function.
Who should consider this trial
Good fit: Ideal candidates are males or non-pregnant females over 21 with end-stage ankle arthritis who require primary total ankle replacement.
Not a fit: Patients with previous ankle fusion surgeries or those requiring revision of existing ankle replacements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and longer-lasting results for patients undergoing ankle replacement surgery.
How similar studies have performed: While similar approaches have been explored, the specific combination of technologies in this study represents a novel advancement in ankle replacement.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newcastle
- Northumbria Healthcare NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Steven Liggett
- Email: steven.liggett@nhs.net
- Phone: 44+ 01642 850850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.