RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 Re

Первичные конечные точки

• Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From day of surgery through 12 weeks postoperatively]

Вторичные конечные точки (2)

• Passive wrist range of motion (ROM) in degrees measured to assess functional recovery [Срок оценки: 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) [Срок оценки: At 52 and/or 104 weeks postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07028541 · 243-03-CI-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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