Bioactive Glass Composite Implants in Cranial Bone Reconstruction

Turku University Hospital (TYKS)

Status

Unknown

Conditions

Bone Substitutes

Treatments

Device: Composite Implant

Study type

Observational

Funder types

Other

Identifiers

NCT01202838

MP125/2008

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients with cranial bone defect larger than 4x4 cm after trauma or tumor surgery
patient signs written study consent

Exclusion criteria

patient is unlikely to adhere to study procedures
patient has a disease or condition that in the opinion of investigator is contraindicating participation
patient is participating another medical device or drug trial