Bioactive Glass Composite Implants in Cranial Bone Reconstruction

Bone Substitutes Clinical Trial

Official title:

Bioactive Glass Composite Implants in Cranial Bone Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01202838
• Other study ID #: MP125/2008
• Status: Recruiting
• Phase: Phase 0
• First received: July 26, 2010
• Last updated: September 14, 2010
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2010
• Source: Turku University Hospital
• Contact: Matti J Peltola, MD, PhD, DDS
• Phone: +35823130000
• Email: matti.peltola[@]tyks.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish National Agency for Medicines
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Substitutes

Intervention

Device:
• Composite Implant
Subjects receiving composite implants

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Turku

Country where clinical trial is conducted

Finland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	Clinical success is evaluated using clinical and radiographic examination, and blood count.	3 years	Yes