NCT01202838

Bioactive Glass Composite Implants in Cranial Bone Reconstruction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study composites of bioactive glass and methylmetacrylate with glass fibre reinforcement in cranial bone defect reconstruction.

Detailed description

Traditional skull and facial bone reconstructions with hard tissues have a long history with good clinical outcomes. However, they have certain disadvantages. The benefits of synthetic materials are the avoidance of donor-site morbidity and scars, but also shorter hospitalization time, lower expenses and known composition. Custom-made skull bone implant can produced based on patients clinical need utilizing rapid prototyping technologies. This will result in very high accuracy of the form of the skull defect. Polymethylmetacrylate (PMMA) is one of the most widely used alloplastic material in surgery. Bioactive glass S53P4 (BAG) particles have been used in various clinical indications. BAG was added to composite implant of PMMA with glass fibre reinforcement to enhance bone ingrowth to implant, and to utilize BAG's antimicrobial effects. Ten patients cranial defects are treated with composite implants.

Conditions

• Bone Substitutes

Interventions

Type	Name	Description
DEVICE	Composite Implant	Subjects receiving composite implants

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-09-16
• Last updated: 2010-09-16

Locations

1 site across 1 country: Finland