RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children

Bioretec

Status: Not yet enrolling

Conditions: Distal Radius Fracture; Fracture Fixation, Internal

Treatments: Device: Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children

Study type: Interventional

Funder types: Industry

Identifiers

NCT07028541

243-03-CI-02

Details and patient eligibility

About

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.

Full description

This single-arm, open-label, monocenter clinical investigation is conducted in accordance with ISO 14155 to evaluate the safety and performance of the RemeOs™ DrillPin (a bioresorbable magnesium-based implant) used for internal fixation of distal radius fractures in pediatric patients.

Eligible participants are children aged over 5 and under 14 years who require surgical fixation of a distal radius fracture. The RemeOs™ DrillPin is designed to offer stable fracture fixation while gradually resorbing in the body, potentially reducing the need for implant removal.

Primary objectives include evaluating implantation success-defined by low pain levels (FACES® Pain Rating Scale score <3) and radiographic fracture healing in at least three cortices out of four across two imaging planes at 12 weeks postoperatively-and assessing short-term safety by monitoring adverse events, including device-related and serious adverse events.

Secondary assessments focus on postoperative clinical function and wrist range of motion (ROM), measured using a goniometer, as well as radiographic markers of implant biodegradation. Long-term safety is evaluated through the monitoring of potential growth disturbances at 52 and 104 weeks, including limb length discrepancies or growth plate abnormalities.

This early-stage investigation aims to generate clinical data on the application of magnesium-based resorbable implants in pediatric fracture care and to assess their potential to support bone healing without interfering with skeletal development.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Pathological bone lesions (e.g. bone cyst or osteomyelitis)
• Underlying diseases (kidney diseases, uncontrolled diabetes mellitus)
• Polytraumatized patients
• Suspicion of child abuse
• Inability or unwillingness to give informed consent
• Multiple fracture (excluding associated ulna fracture)
• Open Fracture
• Pregnancy (tested in all female patients who have begun menstruation)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RemeOs™ DrillPin for Fixation of Distal Radius Fractures

Experimental group

Treatment:

Device: Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children