Clinical trial NCT01202838: Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Official title: Bioactive Glass Composite Implants in Cranial Bone Reconstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Substitutes
Keywords: Cranial bone reconstruction, composite
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2010-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of Turku university hospital needing cranial bone defect 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.

Eligibility 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

Primary outcomes:
measure: Clinical success
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Matti J Peltola, MD, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peltola MJ, Aitasalo KM, Aho AJ, Tirri T, Suonpaa 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. No abstract available.
citation: Peltola M, Aitasalo K, Suonpaa 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. doi: 10.1002/hed.20436.
citation: Tuusa SM, Peltola MJ, Tirri T, Puska MA, Roytta 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. doi: 10.1002/jbm.b.30898.
citation: Lepparanta O, Vaahtio M, Peltola T, Zhang D, Hupa L, Hupa M, Ylanen 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. doi: 10.1007/s10856-007-3018-5. Epub 2007 Jul 10.
citation: Munukka E, Lepparanta O, Korkeamaki M, Vaahtio M, Peltola T, Zhang D, Hupa L, Ylanen 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. doi: 10.1007/s10856-007-3143-1. Epub 2007 Jun 14.