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

July 8, 2009 updated by: Vivoxid Ltd

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, FI-20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who participated to previous clinical investigations with bioactive glass about 10 years ago.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivoxid Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 9, 2009

Last Update Submitted That Met QC Criteria

July 8, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1005-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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