Trials / Completed
CompletedNCT04571905
MagnezixKids Study
"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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Thomas Krebs · Academic / Other
- Sex
- All
- Age
- 3 Years – 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Magnesium-based
- Bioresrobable Implants
- Pediatric Elbow Fractures
- Osteosynthesis
- Childhood
- Magnezix
- Elbow Fracture
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Osteosynthesis with resorbable Material | Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2023-07-12
- Completion
- 2023-07-12
- First posted
- 2020-10-01
- Last updated
- 2023-09-06
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04571905. Inclusion in this directory is not an endorsement.