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Bioactive Glass Composite Implants in Cranial Bone Reconstruction

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ClinicalTrials.gov Identifier: NCT01202838
Recruitment Status : Unknown
Verified September 2010 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Bone Substitutes Device: Composite Implant Early Phase 1

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 Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Study Start Date : June 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Composite Implant
Subject receiving composite implant
Device: Composite Implant
Subjects receiving composite implants


Outcome Measures

Primary Outcome Measures :
  1. Clinical success [ Time Frame: 3 years ]
    Clinical success is evaluated using clinical and radiographic examination, and blood count.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients of Turku university hospital needing cranial bone defect reconstruction
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202838


Contacts
Contact: Matti J Peltola, MD, PhD, DDS +35823130000 matti.peltola@tyks.fi
Contact: Kalle MJ Aitasalo, MD, PhD, DDS +35823130000 kalle.aitasalo@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Principal Investigator: Matti J Peltola, MD, PhD, DDS         
Sponsors and Collaborators
Turku University Hospital
University of Turku
Investigators
Principal Investigator: Matti J Peltola, MD, PhD, DDS Turku University Hospital
More Information

Publications:
Responsible Party: Matti Peltola, adjunct professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01202838     History of Changes
Other Study ID Numbers: MP125/2008
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010

Keywords provided by Turku University Hospital:
Cranial bone reconstruction, composite