RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children

NCT07028541 | Not Yet Recruiting

• 1 other identifier: 243-03-CI-02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fracture Fixation, Internal; Distal Radius Fracture

Keywords

Distal radius; fracture; RemeOs; DrillPin; Biodegradable Implant

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  From day of surgery through 12 weeks postoperatively

Secondary Outcomes (2)

• Passive wrist range of motion (ROM) in degrees measured to assess functional recovery

  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)

  At 52 and/or 104 weeks postoperatively

Study Arms (1)

RemeOs™ DrillPin for Fixation of Distal Radius Fractures

EXPERIMENTAL

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

Interventions

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

RemeOs™ DrillPin for Fixation of Distal Radius Fractures

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Distal Radius Fractures
• Written informed consent of the parent, oral agreement of the patient documented as informant consent of the child

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bioretec Ltd.: lead

Related Publications (4)

• 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.

  PMID: 31579775 RESULT

• Sturznickel 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.

  PMID: 33775413 RESULT

• Ramoutar 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.

  PMID: 25331168 RESULT

• Holweg 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.

  PMID: 32553919 RESULT

MeSH Terms

Conditions

Wrist Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries

Central Study Contacts

Dr Clemens Seidl

CONTACT

+432236 9004; unfallchirurgie@baden.lknoe.at

Prof. Dr. Dr. Thomas Klestil

CONTACT

+43 2236 9004 13201; thomas.klestil@moedling.lknoe.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share