3D-Printed Patient-Specific Casts for the Distal Radius in Children: Outcome and Pre-Market Survey

Area of Science:

• Orthopaedic surgery
• Biomedical engineering
• Pediatric trauma

Background:

• 3D technology adoption is transforming orthopaedic and trauma surgery.
• Patient-specific 3D-manufactured splints and casts show promise, especially for pediatric applications.
• Assessing the safety of novel 3D-printed casts is crucial for clinical implementation.

Purpose of the Study:

• To evaluate the safety and clinical outcomes of patient-specific 3D casts in children with distal radius fractures.
• To assess pain, skin integrity, and patient acceptance of the novel 3D cast.
• To confirm the mechanical integrity of the 3D-printed cast.

Main Methods:

• A clinical outcome and pre-marketing study involving 10 pediatric patients with distal radius fractures.
• Application of newly developed patient-specific 3D casts.
• Three consecutive evaluations over 21 days measuring pain (VAS), skin lesions (NPUAP/EPUAP), comfort and acceptance (PANAS-C, SAM, Likert scale).
• Mechanical analysis of the 3D-printed cast.

Main Results:

• Consistently positive results were observed across all investigated domains.
• High levels of general comfort, effective fracture containment, and mechanical integrity of the 3D-printed casts were reported.
• The practicability of the supply chain for 3D cast production was also confirmed.

Conclusions:

• Patient-specific 3D printed casts, created with specialized software, demonstrate safety for managing pediatric distal radius "buckle" fractures (Level IV evidence).
• The findings support the extension of this technology to treat more complex fractures in children.
• This study highlights the potential of 3D printing in pediatric orthopaedic trauma care.