RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children (NCT07028541) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
20 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range
5 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation)
Timeframe: At 12 weeks postoperatively
2
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
3
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