Bioactive Glass Composite Implants in Cranial Bone Reconstruction

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01202838

Enrollment

Registered

2010-09-16

Start date

2008-06-30

Completion date

2012-12-31

Last updated

2010-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Substitutes

Keywords

Cranial bone reconstruction, composite

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.

Interventions

DEVICEComposite Implant

Subjects receiving composite implants

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical success	3 years	Clinical success is evaluated using clinical and radiographic examination, and blood count.

Countries

Finland

Contacts

Primary ContactMatti J Peltola, MD, PhD, DDS

matti.peltola@tyks.fi+35823130000

Backup ContactKalle MJ Aitasalo, MD, PhD, DDS

kalle.aitasalo@tyks.fi+35823130000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026