Bioactive Glass Composite Implants in Cranial Bone Reconstruction

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

Study Overview

• Status: Unknown
• Conditions: Bone Substitutes
• Intervention / Treatment: Device: Composite Implant

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: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Matti J Peltola, MD, PhD, DDS; Phone Number: +35823130000; Email: matti.peltola@tyks.fi
• Study Contact Backup: Name: Kalle MJ Aitasalo, MD, PhD, DDS; Phone Number: +35823130000; Email: kalle.aitasalo@tyks.fi

Study Locations

• Finland
  • Turku, Finland, 20521
    • Recruiting
    • Turku University Hospital
    • Principal Investigator: Matti J Peltola, MD, PhD, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients of Turku university hospital needing cranial bone defect reconstruction

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Composite Implant; Subject receiving composite implant	Device: Composite Implant; Subjects receiving composite implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Clinical success is evaluated using clinical and radiographic examination, and blood count.	3 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku
• Investigators: Principal Investigator: Matti J Peltola, MD, PhD, DDS, Turku University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): September 16, 2010
• Last Update Submitted That Met QC Criteria: September 14, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Cranial bone reconstruction, composite
• Other Study ID Numbers: MP125/2008