Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-05 @ 12:19 AM
Study NCT ID:
NCT02521103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2015-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triathlon Tritanium Cone Augments Outcomes Study
Sponsor:
Stryker Orthopaedics
Organization:
Study Overview
Official Title:
A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
None
Brief Summary:
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: