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Bioactive Glass Composite Implants in Cranial Bone Reconstruction

NCT ID: NCT01202838

Last Updated: 2010-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Bone Substitutes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Composite Implant

Subject receiving composite implant

Composite Implant

Intervention Type DEVICE

Subjects receiving composite implants

Interventions

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Composite Implant

Subjects receiving composite implants

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Turku University Hospital

Principal Investigators

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Matti J Peltola, MD, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Matti J Peltola, MD, PhD, DDS

Role: CONTACT

[email protected]
+35823130000

Kalle MJ Aitasalo, MD, PhD, DDS

Role: CONTACT

[email protected]
+35823130000

References

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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.

Reference Type BACKGROUND
PMID: 18634960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16823870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17618510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17619981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17569007 (View on PubMed)

Other Identifiers

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MP125/2008

Identifier Type: -

Identifier Source: org_study_id