Status:
TERMINATED
INFINITY™Total Ankle Replacement Follow-up
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
21+ years
Brief Summary
Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Tota...
Detailed Description
The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures ar...
Eligibility Criteria
Inclusion
- Be 21 years of age or older 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™ Total Ankle System replacement prior to enrollment in the research.
Exclusion
- 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.
Key Trial Info
Start Date :
October 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03277989
Start Date
October 9 2017
End Date
March 31 2023
Last Update
February 14 2025
Active Locations (9)
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1
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
2
Orthopaedic & Spine Center of the Rockies
Fort Collins, Colorado, United States, 80525
3
Illinois Bone & Joint Institute
Libertyville, Illinois, United States, 60048
4
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States, 49525