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INFINITY™ With ADAPTIS™ Technology Study

Active Not RecruitingN/A

Sponsor: Stryker Trauma and Extremities

Conditions: Arthritis, Rheumatoid

Interventions: INFINITY™ with ADAPTIS™ Technology Total Ankle System

Countries: United States

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 overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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

Locations (13)

Gilbert, Arizona, United States
Rancho Mirage, California, United States
Aurora, Colorado, United States
Vail, Colorado, United States
Trinity, Florida, United States
Maywood, Illinois, United States
New York, New York, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States