Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 1:45 PM
Study NCT ID:
NCT04594993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INFINITY™ With ADAPTIS™ Technology Study
Sponsor:
Stryker Trauma and Extremities
Organization:
Study Overview
Official Title:
INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITAR2
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: