Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:36 PM
Study NCT ID:
NCT01282294
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2011-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
Sponsor:
Synthes GmbH
Organization:
Study Overview
Official Title:
Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails
Status:
COMPLETED
Status Verified Date:
2015-02
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 post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: