Clinical Research Directory
Browse clinical research sites, groups, and studies.
RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
Sponsor: Bioretec Ltd.
Summary
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.
Official title: To Evaluate the Feasibility of the Clinical Application of Mg-based RemeOs™ DrillPin for Fixation of Fractures of the Distal Radius in Children From the Age of Over 5 and Under 14.
Key Details
Gender
All
Age Range
5 Years - 13 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-09
Completion Date
2027-12
Last Updated
2025-06-19
Healthy Volunteers
No
Interventions
Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
This is a first-in-child clinical investigation of a bioresorbable magnesium alloy DrillPin (RemeOs™) for fixation of distal radius fractures in children aged 5 to \<14 years. The implant is investigational, not CE-marked or FDA-approved, and represents a novel alternative to traditional metallic implants. It gradually degrades in vivo, eliminating the need for removal. The study focuses on safety and feasibility in a pediatric population, supported by preclinical data from a similar Mg-based RemeOs™ Screw. The DrillPin's material and design are intended to support bone healing without growth disturbances, offering a state-of-the-art, bioresorbable solution tailored for growing patients.