RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorBioretec Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pathological bone lesions (e.g. bone cyst or osteomyelitis)
Underlying diseases (kidney diseases, uncontrolled diabetes mellitus)
Polytraumatized patients
Suspicion of child abuse
Trial design
Design model
Single group
Treatments tested in this trial
Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
DeviceThis 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RemeOs™ DrillPin for Fixation of Distal Radius FracturesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation)
This outcome is one of two predefined criteria used to determine successful implantation. Pain will be measured using the FACES® Pain Rating Scale. A score of less than 3 at 12 weeks postoperatively is considered a successful pain outcome. The FACES® Pain Rating Scale ranges from 0 (no pain) to 10 (worst pain).
Time frame
At 12 weeks postoperatively2
Number of participants with radiographic healing in at least 3 of 4 cortices on two-plane radiographs (criterion of successful implantation)
This outcome is one of two predefined criteria used to determine successful implantation. Radiographic healing will be assessed at 12 weeks postoperatively using standard anteroposterior and lateral radiographs. Healing is defined as the presence of visible callus formation in at least 3 of the 4 cortices (outer bone surfaces visible on two-plane imaging). Callus formation indicates new bone growth bridging the fracture site, and ≥3 healed cortices reflects adequate fracture consolidation.
Time frame
At 12 weeks postoperatively3
Number of participants with at least one adverse event (AE), adverse device effect (ADE), serious adverse event (SAE), or serious adverse device effect (SADE)
Safety will be assessed by documenting the occurrence, type, severity, and investigator-assessed relationship to the investigational device or implantation procedure for all adverse events. Events include adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), and serious adverse device effects (SADEs). The assessment will cover the period from surgery through 12 weeks postoperatively and will be based on clinical observations, subject reports, and medical record review.
Time frame
From day of surgery through 12 weeks postoperativelySecondary outcomes
1
Passive wrist range of motion (ROM) in degrees measured to assess functional recovery
Passive wrist range of motion (ROM) will be measured in degrees (°) using a goniometer at 2, 4, 6 (optional), 12, 26, 52, and 104 weeks postoperatively. The following directions of movement will be assessed independently: Extension/Flexion, Abduction/Adduction, Pronation/Supination. Measurements are recorded separately for the affected wrist and the contralateral (uninjured) wrist. Each direction will be expressed in degrees, and data will be used to evaluate functional recovery of wrist mobility over time.
Time frame
2, 4, 6 (optional), 12, 26, 52, and 104 weeks postoperatively2
Number of participants with radiographic evidence of growth disturbance (growth arrest or length discrepancy)
Radiographic evaluation for growth disturbance will be performed at 52 and/or 104 weeks postoperatively if clinical assessment suggests axis deviation or deformity. A participant will be recorded as having a growth disturbance if either of the following is observed: Growth arrest or length discrepancy . This outcome will be reported as a binary (Yes/No) result per participant.
Time frame
At 52 and/or 104 weeks postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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