Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Study Details
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 |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Composite Implant Subject receiving composite implant |
Device: Composite Implant
Subjects receiving composite implants
|
Outcome Measures
Primary Outcome Measures
- Clinical success [3 years]
Clinical success is evaluated using clinical and radiographic examination, and blood count.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Turku University Hospital | Turku | Finland | 20521 |
Sponsors and Collaborators
- Turku University Hospital
- University of Turku
Investigators
- Principal Investigator: Matti J Peltola, MD, PhD, DDS, Turku University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Leppäranta O, Vaahtio M, Peltola T, Zhang D, Hupa L, Hupa M, Ylänen H, Salonen JI, Viljanen MK, Eerola E. Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro. J Mater Sci Mater Med. 2008 Feb;19(2):547-51. Epub 2007 Jul 10.
- Munukka E, Leppäranta O, Korkeamäki M, Vaahtio M, Peltola T, Zhang D, Hupa L, Ylänen H, Salonen JI, Viljanen MK, Eerola E. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria. J Mater Sci Mater Med. 2008 Jan;19(1):27-32. Epub 2007 Jun 14.
- Peltola M, Aitasalo K, Suonpää J, Varpula M, Yli-Urpo A. Bioactive glass S53P4 in frontal sinus obliteration: a long-term clinical experience. Head Neck. 2006 Sep;28(9):834-41.
- Peltola MJ, Aitasalo KM, Aho AJ, Tirri T, Suonpää JT. Long-term microscopic and tissue analytical findings for 2 frontal sinus obliteration materials. J Oral Maxillofac Surg. 2008 Aug;66(8):1699-707. doi: 10.1016/j.joms.2007.11.020.
- Tuusa SM, Peltola MJ, Tirri T, Puska MA, Röyttä M, Aho H, Sandholm J, Lassila LV, Vallittu PK. Reconstruction of critical size calvarial bone defects in rabbits with glass-fiber-reinforced composite with bioactive glass granule coating. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):510-9.
- MP125/2008