INFINITY™ With ADAPTIS™ Technology Study (ITAR2)

Stryker Trauma and Extremities

Status: Active, not recruiting

Conditions: Arthritis, Rheumatoid

Treatments: Device: INFINITY™ with ADAPTIS™ Technology Total Ankle System

Study type: Observational

Funder types: Industry

Identifiers

NCT04594993

US20-TAR-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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