INFINITY™ With ADAPTIS™ Technology Study
Purpose
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
- Arthritis, Rheumatoid
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
More Details
- Status
- Active, not recruiting
- Sponsor
- Stryker Trauma and Extremities
Study Contact
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.