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.
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Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation)
Timeframe: At 12 weeks postoperatively
Number of participants with radiographic healing in at least 3 of 4 cortices on two-plane radiographs (criterion of successful implantation)
Timeframe: At 12 weeks postoperatively
Number of participants with at least one adverse event (AE), adverse device effect (ADE), serious adverse event (SAE), or serious adverse device effect (SADE)
Timeframe: From day of surgery through 12 weeks postoperatively