Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Observational

INFINITY™ With ADAPTIS™ Technology Study

NCT04594993 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2021-02-09
Last updated
2026-08-25

Condition(s) studied

Arthritis, Rheumatoid

Investigational drug(s) / intervention(s)

INFINITY™ with ADAPTIS™ Technology Total Ankle System

INFINITY™ with ADAPTIS™ Technology Total Ankle System: Total Ankle Replacement

Study summary

INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up to 13 sites

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Be over 22 years of age at the time of surgery; * Diagnosed with unilateral and/or bilateral ankle joint disease; * Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; * Willing and able to consent to participate (written, informed consent; * Willing and able to attend the requested follow-up visits; * A clinical decision has been made to use INFINITY™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment. Exclusion Criteria: * Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement; * Subjects requiring revision total ankle replacement of the ankle being considered for study

Primary outcome measure(s)

  • Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years — 10 years
    Assess the 10-year survivorship of 200 patients implanted with the INFINITY™ with ADAPTIS™ Technology Total Ankle System is non-inferior to other, similar devices.

Trial sites (13)

FacilityCityRegionStatus
OrthoArizona Foot and Ankle Institute Gilbert Arizona
Eisenhower Health / Desert Orthopedic Center Rancho Mirage California
University of Colorado Orthopedic Research Center Aurora Colorado
Steadman Philippon Research Institute Vail Colorado
Florida Joint Care Institute Trinity Florida
Loyola University Medical Center Maywood Illinois
Hospital for Special Surgery New York New York
Slocum Research & Education Foundation Eugene Oregon
Southern Oregon Orthopedics Medford Oregon
Medical University of South Carolina Charleston South Carolina
Erlanger Institute for Clinical Research Chattanooga Tennessee
Campbell Clinic Germantown Tennessee
Vanderbilt University Medical Center Nashville Tennessee
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04594993 on ClinicalTrials.gov ↗ ← All trials in the USA