Fracture Fixation, InternalNCT07028541
RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children
A study testing Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children in people with Fracture Fixation, Internal and Distal Radius Fracture, run by Bioretec Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Fracture Fixation, Internal, Distal Radius Fracture
- What is being tested?
- Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Evaluate the Feasibility of the Clinical Application of Mg-based RemeOs™ DrillPin for Fixation of Fractures of the Distal Radius in Children From the Age of Over 5 and Under 14.
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.
Read the detailed 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.
- Being tested
- Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
- Keywords
- Distal radius, fracture, RemeOs, DrillPin, Biodegradable Implant
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in childrenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RemeOs™ DrillPin for Fixation of Distal Radius Fractures | Experimental | Not described Receives: Device: Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: From day of surgery through 12 weeks postoperatively
Secondary outcomes (2)
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.
Measured: 2, 4, 6 (optional), 12, 26, 52, and 104 weeks postoperatively
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.
Measured: At 52 and/or 104 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fracture Fixation, InternalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioretec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028541
- Sponsor's protocol ID
- 243-03-CI-02
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study data are pseudonymized and retained only by the investigator site with no access to direct identifiers by the sponsor. The sponsor only receives pseudonymized data for analysis and regulatory use.
Publications
Grun NG, Holweg PL, Donohue N, Klestil T, Weinberg AM. Resorbable implants in pediatric fracture treatment. Innov Surg Sci. 2018 May 29;3(2):119-125. doi: 10.1515/iss-2018-0006. eCollection 2018 Jun.
PubMed 31579775Sturznickel J, Delsmann MM, Jungesblut OD, Stucker R, Knorr C, Rolvien T, Kertai M, Rupprecht M. Safety and performance of biodegradable magnesium-based implants in children and adolescents. Injury. 2021 Aug;52(8):2265-2271. doi: 10.1016/j.injury.2021.03.037. Epub 2021 Mar 18.
PubMed 33775413Ramoutar DN, Shivji FS, Rodrigues JN, Hunter JB. The outcomes of displaced paediatric distal radius fractures treated with percutaneous Kirschner wire fixation: a review of 248 cases. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):471-6. doi: 10.1007/s00590-014-1553-6. Epub 2014 Oct 21.
PubMed 25331168Holweg P, Berger L, Cihova M, Donohue N, Clement B, Schwarze U, Sommer NG, Hohenberger G, van den Beucken JJJP, Seibert F, Leithner A, Loffler JF, Weinberg AM. A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model. Acta Biomater. 2020 Sep 1;113:646-659. doi: 10.1016/j.actbio.2020.06.013. Epub 2020 Jun 14.
PubMed 32553919
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Feasibility of the Clinical Application of Mg-based RemeOs™ DrillPin for Fixation of Fractures of the Distal Radius in Children From the Age of Over 5 and Under 14.
- ClinicalTrials.gov ID
- NCT07028541
- Acronym / sponsor ID
- 243-03-CI-02
- Keywords
- Distal radius, fracture, RemeOs, DrillPin, Biodegradable Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bioretec Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RemeOs™ DrillPin for Fixation of Distal Radius Fractures | Experimental | Device: Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in childrenThis 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. | Device | RemeOs™ DrillPin for Fixation of Distal Radius Fractures |
Primary outcome
Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation)
Time frame: At 12 weeks postoperatively
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).
Number of participants with radiographic healing in at least 3 of 4 cortices on two-plane radiographs (criterion of successful implantation)
Time frame: At 12 weeks postoperatively
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.
Number of participants with at least one adverse event (AE), adverse device effect (ADE), serious adverse event (SAE), or serious adverse device effect (SADE)
Time frame: From day of surgery through 12 weeks postoperatively
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.
2 secondary outcomes
Passive wrist range of motion (ROM) in degrees measured to assess functional recovery
Time frame: 2, 4, 6 (optional), 12, 26, 52, and 104 weeks postoperatively
Number of participants with radiographic evidence of growth disturbance (growth arrest or length discrepancy)
Time frame: At 52 and/or 104 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Results publication: PubMed 31579775Grun NG, Holweg PL, Donohue N, Klestil T, Weinberg AM. Resorbable implants in pediatric fracture treatment. Innov Surg Sci. 2018 May 29;3(2):119-125. doi: 10.1515/iss-2018-0006. eCollection 2018 Jun.
- Results publication: PubMed 33775413Sturznickel J, Delsmann MM, Jungesblut OD, Stucker R, Knorr C, Rolvien T, Kertai M, Rupprecht M. Safety and performance of biodegradable magnesium-based implants in children and adolescents. Injury. 2021 Aug;52(8):2265-2271. doi: 10.1016/j.injury.2021.03.037. Epub 2021 Mar 18.
- Results publication: PubMed 25331168Ramoutar DN, Shivji FS, Rodrigues JN, Hunter JB. The outcomes of displaced paediatric distal radius fractures treated with percutaneous Kirschner wire fixation: a review of 248 cases. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):471-6. doi: 10.1007/s00590-014-1553-6. Epub 2014 Oct 21.
- Results publication: PubMed 32553919Holweg P, Berger L, Cihova M, Donohue N, Clement B, Schwarze U, Sommer NG, Hohenberger G, van den Beucken JJJP, Seibert F, Leithner A, Loffler JF, Weinberg AM. A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model. Acta Biomater. 2020 Sep 1;113:646-659. doi: 10.1016/j.actbio.2020.06.013. Epub 2020 Jun 14.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study data are pseudonymized and retained only by the investigator site with no access to direct identifiers by the sponsor. The sponsor only receives pseudonymized data for analysis and regulatory use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children in people with Fracture Fixation, Internal and Distal Radius Fracture, run by Bioretec Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Clemens Seidl (+432236 9004, unfallchirurgie@baden.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation) (time frame: At 12 weeks postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07028541, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.