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
  Purpose

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


Condition Intervention Phase
Bone Substitutes
Device: Composite Implant
Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bioactive Glass Composite Implants in Cranial Bone Reconstruction

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Clinical success [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Clinical success is evaluated using clinical and radiographic examination, and blood count.


Estimated Enrollment: 10
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)
Groups/Cohorts Assigned Interventions
Composite Implant
Subject receiving composite implant
Device: Composite Implant
Subjects receiving composite implants

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 26, 2010
Last Updated: September 14, 2010
Health Authority: Finland: Finnish National Agency for Medicines

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

ClinicalTrials.gov processed this record on October 21, 2014