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ENROLLING BY INVITATION
NCT06792864
PHASE3

Effectiveness of 3D Bone Matrix in Cranioplasty

Sponsor: Universidad Austral de Chile

View on ClinicalTrials.gov

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

Interventions

DEVICE

OsteoprintCR

Hybrid technique of 3D printed bone matrix based on polycaprolactone with tricalcium beta phosphate

DEVICE

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