Bioactive Glass Composite Implants in Cranial Bone Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Turku University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Turku
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01202838
First received: July 26, 2010
Last updated: September 14, 2010
Last verified: September 2010

July 26, 2010
September 14, 2010
June 2008
December 2012   (final data collection date for primary outcome measure)
Clinical success [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Clinical success is evaluated using clinical and radiographic examination, and blood count.
Same as current
Complete list of historical versions of study NCT01202838 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Bioactive Glass Composite Implants in Cranial Bone Reconstruction

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

patients of Turku university hospital needing cranial bone defect reconstruction

Bone Substitutes
Device: Composite Implant
Subjects receiving composite implants
Composite Implant
Subject receiving composite implant
Intervention: Device: Composite Implant

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Matti J Peltola, MD, PhD, DDS +35823130000 matti.peltola@tyks.fi
Contact: Kalle MJ Aitasalo, MD, PhD, DDS +35823130000 kalle.aitasalo@tyks.fi
Finland
 
NCT01202838
MP125/2008
No
Matti Peltola, adjunct professor, Turku University Hospital
Turku University Hospital
University of Turku
Principal Investigator: Matti J Peltola, MD, PhD, DDS Turku University Hospital
Turku University Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP