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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00935870
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : July 9, 2009
Sponsor:
Information provided by:

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
Depressed Lateral Condyle Fracture Benign Bone Tumour Cavity Spinal Fusion 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 : January 2008
Primary Completion Date : June 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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)


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who participated to previous clinical investigations with bioactive glass about 10 years ago.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935870


Locations
Finland
Turku University Hospital
Turku, Finland, FI-20521
Sponsors and Collaborators
Vivoxid Ltd
Investigators
Principal Investigator: Nina Lindfors, MD Turku University Hospital/Helsinki University Hospital
More Information

Responsible Party: Kirsi Rosenqvist, Clinical Research Manager, Vivoxid Ltd
ClinicalTrials.gov Identifier: NCT00935870     History of Changes
Other Study ID Numbers: 1005-3
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Depression
Bone Neoplasms
Behavioral Symptoms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors