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Effectiveness of 3D Bone Matrix in Cranioplasty

NCT06792864 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-01-27

No results posted yet for this study

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.

Conditions

  • Cranioplasty
  • Craniotomy
  • Craniotomy Clipping
  • Craniotomy Surgery
  • Craniocerebral Trauma
  • Craniocerebral Injuries

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".

Sponsors & Collaborators

  • Universidad Austral de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-03-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792864 on ClinicalTrials.gov