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Bioactive Glass Composite Implants in Cranial Bone Reconstruction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Turku University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202838
First Posted: September 16, 2010
Last Update Posted: September 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Turku
Information provided by:
Turku University Hospital
July 26, 2010
September 16, 2010
September 16, 2010
June 2008
December 2012   (Final data collection date for primary outcome measure)
Clinical success [ Time Frame: 3 years ]
Clinical success is evaluated using clinical and radiographic examination, and blood count.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01202838
MP125/2008
No
Not Provided
Not Provided
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