Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Recruitment status was Recruiting
The purpose of this study is to study composites of bioactive glass and methylmetacrylate with glass fibre reinforcement in cranial bone defect reconstruction.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Bioactive Glass Composite Implants in Cranial Bone Reconstruction|
- Clinical success [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Clinical success is evaluated using clinical and radiographic examination, and blood count.
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Subject receiving composite implant
Device: Composite Implant
Subjects receiving composite implants
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202838
|Contact: Matti J Peltola, MD, PhD, DDSfirstname.lastname@example.org|
|Contact: Kalle MJ Aitasalo, MD, PhD, DDSemail@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20521|
|Principal Investigator: Matti J Peltola, MD, PhD, DDS|
|Principal Investigator:||Matti J Peltola, MD, PhD, DDS||Turku University Hospital|