Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 12:21 AM
Study NCT ID:
NCT04571905
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2020-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MagnezixKids Study
Sponsor:
Thomas Krebs
Organization:
Study Overview
Official Title:
"Magnesium-based, Bioresorbable Implants for Pediatric Elbow Fractures, a Single Center Pilot Study for Osteosynthesis With Magnezix Screws in Fractures of the Epicondylus Ulnaris and Condylus Radialis."
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The overall objective of the study is to describe the outcomes of osteosyn-thesis with magnesium based screws in children with a primary or second-ary (within 7 days from trauma) dislocated fracture of the Epicondyles ul-naris or Condylus radialis, and to compare them with outcomes of conven-tional osteosynthesis using steel screws.
If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.
If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the procedure could be tested formally in a subsequent full-size study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: