RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorBioretec Ltd.
About this trial
This is a pre-market, single-arm, open-label, monocenter clinical investigation evaluating the safety and performance of the magnesium (Mg)-based bioresorbable RemeOs™ DrillPin for surgical fixation of distal radius fractures in pediatric patients. The study will enroll 20 children aged over 5 and under 14 years to assess implantation success, early safety outcomes, and long-term effects on growth and bone healing.
Eligibility criteria
Qualifiers
Distal Radius Fractures
Written informed consent of the parent, oral agreement of the patient documented as informant consent of the child
Subject and parents have been informed of the nature of the study, agrees to participate and parent signs the approved consent form. • Female patients in childbearing age (female patients who have begun menstruation) perform a pregnancy test prior inclusion
Disqualifiers
Pathological bone lesions (e.g. bone cyst or osteomyelitis)
Underlying diseases (kidney diseases, uncontrolled diabetes mellitus)
Polytraumatized patients
Suspicion of child abuse
Trial design
Treatments tested in this trial
- Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov