INFINITY™ With ADAPTIS™ Technology Study

NCT04594993 · tracked via the Priya Life Science USA tracker

Sponsor

Stryker Trauma and Extremities

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

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)

Facility	City	Region
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

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Other trials for the same condition

R-2487 in Patients With Rheumatoid Arthritis Recruiting

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) Active, not recruiting

A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis Recruiting

IMPACT - AndHealth Autoimmune Research Registry Recruiting

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