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Effectiveness of 3D Bone Matrix in Cranioplasty
Sponsor: Universidad Austral de Chile
Summary
The objective of this clinical trial is to evaluate the effectiveness of a 3D bone scaffold in relation to a scaffold formed by PCL + β-TCP (polycaprolactone and beta-tricalcium phosphate), compared to the use of PMMA (polymethyl methacrylate) acrylic cement for bone regeneration in patients undergoing cranioplasty in the city of Valdivia, Chile, between the years 2024-2025. The main beneficiaries will be patients, users of the public or private health system, who require bone regeneration. The intermediate beneficiaries are the health team: doctors specialized in surgery and orthopedics, dedicated in their professional work to bone reconstruction and regeneration.
Official title: Effectiveness of 3D Printed Polycaprolactone and Tricalcium Phosphate Bone Scaffold for Bone Regeneration in Cranioplasty: Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2024-07-01
Completion Date
2025-12-01
Last Updated
2025-01-27
Healthy Volunteers
Yes
Conditions
Interventions
OsteoprintCR
Hybrid technique of 3D printed bone matrix based on polycaprolactone with tricalcium beta phosphate
SMAR SET GMV Endurance Gentamicin
Patient undergoing cranioplasty with conventional technique using polymethylmethylmethacrylate-based surgical cement brand "SMAR SET GMV Endurance Gentamicin".
Locations (1)
Hospital Base de Valdivia
Valdivia, Chile