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Clinical Study of FRC Implant to Treat Skull Bone Defects

NCT01874613 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-02-19

No results posted yet for this study

Summary

Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects.

Functional and aesthetic outcome is assessed by patient and doctor.

Conditions

  • Cranial Bone Defect
  • Orbital Base Fracture

Interventions

DEVICE

FRC implant reconstruction

A cranioplasty with the FRC implant is performed.

DEVICE

FRC implant reconstruction

The orbital floor fracture is reconstructed with the FRC implant.

Sponsors & Collaborators

  • Oulu University Hospital

    collaborator OTHER

  • Turku Clinical Biomaterials Centre

    collaborator UNKNOWN

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Kalle J Aitasalo, Professor · Turku University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-12-31
Completion
2019-12-31

Countries

  • Finland

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 NCT01874613 on ClinicalTrials.gov