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

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