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NCT04594993 | RECRUITING | Arthritis, Rheumatoid


INFINITY™ With ADAPTIS™ Technology Study
Sponsor:

Stryker Trauma and Extremities

Brief 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

Condition or disease

Arthritis, Rheumatoid

Intervention/treatment

INFINITY™ with ADAPTIS™ Technology Total Ankle System

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official Title : INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
Actual Study Start Date : 2021-02-09
Estimated Primary Completion Date : 2033-11
Estimated Study Completion Date : 2035-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

INFINITY™ With ADAPTIS™ Technology Study

Location Details

NCT04594993


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


ACTIVE NOT RECRUITING

United States, Arizona

OrthoArizona Foot and Ankle Institute

Gilbert, arizona, United States, 85234

ACTIVE NOT RECRUITING

United States, California

Eisenhower Health / Desert Orthopedic Center

Rancho Mirage, California, United States, 92270-3221

ACTIVE NOT RECRUITING

United States, Colorado

University of Colorado Orthopedic Research Center

Aurora, Colorado, United States, 80045

ACTIVE NOT RECRUITING

United States, Colorado

Steadman Philippon Research Institute

Vail, Colorado, United States, 81567

ACTIVE NOT RECRUITING

United States, Florida

Florida Joint Care Institute

Trinity, Florida, United States, 34655

RECRUITING

United States, Illinois

Loyola University Medical Center

Maywood, Illinois, United States, 60153

ACTIVE NOT RECRUITING

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

ACTIVE NOT RECRUITING

United States, Oregon

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, United States, 97401

ACTIVE NOT RECRUITING

United States, Oregon

Southern Oregon Orthopedics

Medford, Oregon, United States, 97504

ACTIVE NOT RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

ACTIVE NOT RECRUITING

United States, Tennessee

Erlanger Institute for Clinical Research

Chattanooga, Tennessee, United States, 37403

ACTIVE NOT RECRUITING

United States, Tennessee

Campbell Clinic

Germantown, Tennessee, United States, 38138

ACTIVE NOT RECRUITING

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37203

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