Assessment of 3D-printed patient specific scaffolds for the treatment of temporal hollowing following cranial vault remodelling surgery in children with craniosynostosis.

Osteopore Limited0 个研究点目标入组 5 人开始时间: 2023年9月26日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•Patients must fulfil all the following criteria to be eligible for the trial:
•Clinically appreciable temporal hollowing with a temporal defect (bony and/or soft tissue) evident on CT imaging.
•Patients aged 2 to 18 years of age.
•Patient, and their parent/guardian if applicable, willing and able to comply with the study requirements.
•Guardian (or patient if Gillick competent) capable of providing valid informed consent

•Patients meeting any of the following criteria will be excluded from the trial:
•Current smokers.
•Syndromes associated with poor wound healing.
•Patient or guardian unwilling or unable to provide fully informed consent.
•Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency.
•Known severe concurrent or inter-current illness including but not limited to cardiovascular, respiratory, or immunological illness, psychiatric disorders, or possible allergies (including allergy to PCL) that, at the discretion of the clinical leads, would compromise the participant safety or compliance, or interfere with interpretation of study results.
•Unable or unwilling to comply with the study requirements.
•Unreliable follow up record (i.e. multiple failed attendances for their regular follow-up appointments).

发起方

Osteopore Limited