Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Recruitment status was Recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 26, 2010 | ||||||||
| Last Updated Date | September 14, 2010 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Clinical success [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] Clinical success is evaluated using clinical and radiographic examination, and blood count. |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01202838 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Bioactive Glass Composite Implants in Cranial Bone Reconstruction | ||||||||
| Official Title ICMJE | Bioactive Glass Composite Implants in Cranial Bone Reconstruction | ||||||||
| 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. |
||||||||
| 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 Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | patients of Turku university hospital needing cranial bone defect reconstruction |
||||||||
| Condition ICMJE | Bone Substitutes | ||||||||
| Intervention ICMJE | Device: Composite Implant
Subjects receiving composite implants |
||||||||
| Study Group/Cohort (s) | Composite Implant
Subject receiving composite implant
Intervention: Device: Composite Implant |
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Finland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01202838 | ||||||||
| Other Study ID Numbers ICMJE | MP125/2008 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Matti Peltola, adjunct professor, Turku University Hospital | ||||||||
| Study Sponsor ICMJE | Turku University Hospital | ||||||||
| Collaborators ICMJE | University of Turku | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Turku University Hospital | ||||||||
| Verification Date | September 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||