Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-04-23
2031-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INFINITY™ with ADAPTIS™ and EVERLAST™
INFINITY™ with ADAPTIS™ and EVERLAST™ technology with Poly Insert for patients requiring primary TAA/TAR.
INFINITY™ with ADAPTIS™ and EVERLAST™
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.
Interventions
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INFINITY™ with ADAPTIS™ and EVERLAST™
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
21 Years
ALL
No
Sponsors
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South Tees Hospitals NHS Foundation Trust
OTHER
Northumbria Healthcare NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Northumbria Healthcare NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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NHCT0494
Identifier Type: -
Identifier Source: org_study_id
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