INFINITY™ With ADAPTIS™ Technology Study

Last updated: November 1, 2024
Sponsor: Stryker Trauma and Extremities
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Treatment

INFINITY™ with ADAPTIS™ Technology Total Ankle System

Clinical Study ID

NCT04594993
US20-TAR-001
  • Ages > 22
  • All Genders

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 Criteria

Inclusion

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, ordegenerative 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 TotalAnkle System replacement prior to enrollment.

Exclusion

Exclusion Criteria:

  • Subjects with an ankle condition, as determined by the investigator, to be aninappropriate candidate for a total ankle replacement;

  • Subjects requiring revision total ankle replacement of the ankle being consideredfor study

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: INFINITY™ with ADAPTIS™ Technology Total Ankle System
Phase:
Study Start date:
February 09, 2021
Estimated Completion Date:
November 30, 2035

Study Description

The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with up to 13 investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ With ADAPTIS™ Technology Total Ankle System.

Connect with a study center

  • OrthoArizona Foot and Ankle Institute

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Eisenhower Health / Desert Orthopedic Center

    Rancho Mirage, California 92270-3221
    United States

    Site Not Available

  • University of Colorado Orthopedic Research Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Steadman Philippon Research Institute

    Vail, Colorado 81567
    United States

    Site Not Available

  • Florida Joint Care Institute

    Trinity, Florida 34655
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Slocum Center for Orthopedics & Sports Medicine

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Southern Oregon Orthopedics

    Medford, Oregon 97504
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Erlanger Institute for Clinical Research

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Campbell Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.