NCT04594993

INFINITY™ With ADAPTIS™ Technology Study

INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DEVICE	INFINITY™ with ADAPTIS™ Technology Total Ankle System	Total Ankle Replacement

Timeline

• Start date: 2021-02-09
• Primary completion: 2033-11-01
• Completion: 2035-11-01
• First posted: 2020-10-20
• Last updated: 2026-03-25

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study