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NCT04571905

MagnezixKids Study

Completed NA Last updated 6 September 2023
What this trial tests

NA trial testing Osteosynthesis with resorbable Material in Magnesium-based in 17 participants. Completed in 12 July 2023.

Timeline
1 August 2020
Primary endpoint
12 July 2023
12 July 2023

Quick facts

Lead sponsorThomas Krebs
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date1 August 2020
Primary completion12 July 2023
Estimated completion12 July 2023
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Thomas Krebs

Who can join

Adults 3 to 15, any sex, with Magnesium-based or Bioresrobable Implants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Making Hardware Removal Unnecessary by Using Resorbable Implants for Osteosynthesis in Children.
    Heye P, Matissek C, Seidl C, Varga M, et al · · 2022 · cited 14× · PMID 35455515 · DOI 10.3390/children9040471

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing