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Bioactive Glass as Bone Graft Substitute in Operative Treatment of Bone - a 10 Years Follow-up Study

Sponsor
Vivoxid Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT00935870
Collaborator
(none)
63
Enrollment
1
Location
13
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.

Condition or Disease Intervention/Treatment Phase
  • Device: Bioactive glass and/or autogenous bone

Study Design

Study Type:
Observational
Actual Enrollment :
63 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Bioactive Glass (S53P4) as Bone Graft Substitute in Operative Treatment of Depressed Lateral Condyle Fractures, Benign Bone Tumour Cavities and in Spinal Fusion - a 10 Years Follow-up and Bone Density Study.
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
A

DEPRESSED LATERAL CONDYLE FRACTURE

Device: Bioactive glass and/or autogenous bone
No intervention in the current study (10-year follow-up study)
B

BENIGN BONE TUMOR

Device: Bioactive glass and/or autogenous bone
No intervention in the current study (10-year follow-up study)
C

SPINAL FUSION

Device: Bioactive glass and/or autogenous bone
No intervention in the current study (10-year follow-up study)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Written informed consent obtained; Participation of previous clinical investigation with bioactive glass
    Exclusion Criteria:

    • The subject is unlikely to adhere to study procedures

    • Concurrent disease or condition that in the opinion of the investigator is contraindicating participation

    • Simultaneous participation in another medical device or investigational drug trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku University Hospital Turku Finland FI-20521

    Sponsors and Collaborators

    • Vivoxid Ltd

    Investigators

    • Principal Investigator: Nina Lindfors, MD, Turku University Hospital/Helsinki University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00935870
    Other Study ID Numbers:
    • 1005-3
    First Posted:
    Jul 9, 2009
    Last Update Posted:
    Jul 9, 2009
    Last Verified:
    Jul 1, 2009
    Additional relevant MeSH terms:
    Bone Neoplasms
    Depression

    Study Results

    No Results Posted as of Jul 9, 2009