Australian-Singaporean company Osteopore Limited has partnered with Queensland Children’s Hospital (QCH) to initiate a clinical trial addressing temporal hollowing in children post-cranial vault remodelling surgery. The trial, led by Dr Yun Phua, aims to recruit five paediatric patients by the end of 2026, with follow-up lasting 12 months post-surgery.
The study will evaluate the feasibility of using a 3D-printed, patient-specific polycaprolactone-tricalcium phosphate (PCL-TCP) onlay scaffold, combined with bone marrow aspirate and platelet-rich fibrin (PRF), to restore the frontotemporal contour in affected children. Temporal hollowing, a common issue following cranial vault remodelling for craniosynostosis, affects up to 40% of patients.
Current treatments involve materials like hydroxyapatite and porous polyethylene, typically used when patients reach maturity. The PCL-TCP scaffold offers potential advantages, including support for bone growth and the possibility of implantation through a smaller incision.
Dr Phua highlighted the trial’s potential to enable earlier correction of temporal hollowing, stating, “With a scaffold that can remodel with cranial growth, this trial has the potential to enable earlier correction of temporal hollowing in the paediatric age group, instead of waiting until adulthood.”
The trial has received approval from the Human Research and Ethics Committee at Children’s Health Queensland and is supported by Maddox’s Helping Hand Foundation. Shelley Porter, Director of the Foundation, expressed optimism about the trial’s impact, noting, “We look forward to seeing the outcome of this trial, and the positive impact this treatment could have not only on the patient, but their family.”
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