RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fracture Fixation, Internal Distal Radius Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm interventional study in which all enrolled participants receive the investigational device, the RemeOs™ DrillPin, for surgical fixation of distal radius fractures. All patients are followed using a standardized clinical and radiographic assessment schedule.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RemeOs™ DrillPin for Fixation of Distal Radius Fractures

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No