INFINITY™Total Ankle Replacement Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthritis, Rheumatoid
- Sponsor
- Stryker Trauma and Extremities
- Enrollment
- 155
- Locations
- 9
- Primary Endpoint
- Survivorship at 10 Years
- Status
- Terminated
- Last Updated
- last year
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).
Investigators
Eligibility Criteria
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)