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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Number of participants with pain score <3 on the FACES® Pain Rating Scale (criterion of successful implantation)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)