Effectiveness of 3D Bone Matrix in Cranioplasty

Launched by UNIVERSIDAD AUSTRAL DE CHILE · Jan 23, 2025

Keywords

ClinConnect Summary

The study will be a parallel-arm clinical trial (8 patients randomly divided into 2 groups), where the participants will be patients with cranial defects requiring cranioplasty at the Department of Neurosurgery of Base Hospital of Valdivia, Chile. Previously, data of each participant will be collected, such as sex, age, basic comorbidities and clinical diagnosis.

The outcome variables to be considered in this study are: The volume of bone reconstruction measure in axial computed tomography (CT) using the tool available in Mimics software delivering the value in cm3 , and the scaffold attac...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients between 18 and 70 years of age, with acquired skull defect from neurological surgeries such as:
• • craniocerebral trauma,
• • refractory intracranial arterial hypertension,
• • congenital cranial defects such as hydrocephalus or other similar surgically resolvable defects,
• • who are suitable for reconstruction using a PCL-TCP scaffold system;
• • patients or their guardians are capable of giving valid informed consent.
• Exclusion Criteria:
• • Active infection at the time of study inclusion (in cases of chronic infection, active infections may manifest as a result of a failed trial of antibiotic withdrawal),
• * immunodeficiency such as:
• • HIV,
• • systemic corticosteroid therapy,
• • chemotherapy,
• • synchronous hematologic malignancy,
• • other causes of secondary or primary immunodeficiency;
• • patients with uncontrolled chronic diseases such ascardiovascular, respiratory or immunological diseases,
• • psychiatric disorders not controlled with home pharmacotherapy,
• • Women currently pregnant, breastfeeding or planning to become pregnant within 2 years of reconstruction surgery,
• • patients with a life expectancy of less than 12 months.