INFINITY™Total Ankle Replacement Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 155
- Locations
- 9
- Primary Endpoint
- Survivorship at 10 Years
Study Overview
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 Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 150 with 9 sites
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 are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays)
The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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.
Outcomes
Primary Outcomes
Survivorship at 10 Years
Time Frame: 10 years
The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis.
Secondary Outcomes
- Radiographic Evaluation-physician Reported Questionnaire(Pre-op through 2 years)
- Ankle Osteoarthritis Score (AOS)(Pre-op though 2 years)
- PROMIS Scale v1.2- Global Health(2 years)
- FAOS Questionnaire(2 years)
- TAR Satisfaction Questionnaire(Pre-op through 2 years)