Status:
RECRUITING
The UK ADAPTIS Study
Lead Sponsor:
Northumbria Healthcare NHS Foundation Trust
Collaborating Sponsors:
South Tees Hospitals NHS Foundation Trust
Conditions:
Total Ankle Replacement
Total Ankle Arthroplasty
Eligibility:
All Genders
21+ years
Phase:
NA
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 seve...
Eligibility Criteria
Inclusion
- 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
- Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
- Patient can understand and provide written consent.
Exclusion
- Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.
- Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06941558
Start Date
April 23 2024
End Date
April 1 2031
Last Update
April 23 2025
Active Locations (1)
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1
Northumbria Healthcare NHS Foundation Trust
Newcastle, United Kingdom, NE29 8NH