Bioactive Glass Composite Implants in Cranial Bone Reconstruction

• Conditions: Bone Substitutes
• Interventions: Device: Composite Implant

• Registration Number: NCT01202838
• Lead Sponsor: Turku University Hospital

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-07-26
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-14
• Last Update Submitted: 2010-09-14
• Study First Posted: 2010-09-16
• Last Update Posted: 2010-09-16
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Composite Implant	Composite Implant	Subject receiving composite implant

Primary Outcome Measures

Name	Time	Method
Clinical success	3 years	Clinical success is evaluated using clinical and radiographic examination, and blood count.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland