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

This study has been completed.
Sponsor:
Information provided by:
Vivoxid Ltd
ClinicalTrials.gov Identifier:
NCT00935870
First received: July 7, 2009
Last updated: July 8, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention
Depressed Lateral Condyle Fracture
Benign Bone Tumour Cavity
Spinal Fusion
 Device: Bioactive glass and/or autogenous bone

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vivoxid Ltd:

Enrollment: 63
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kirsi Rosenqvist, Clinical Research Manager, Vivoxid Ltd
ClinicalTrials.gov Identifier: NCT00935870     History of Changes
Other Study ID Numbers: 1005-3
Study First Received: July 7, 2009
Last Updated: July 8, 2009
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Bone Neoplasms
Fractures, Bone
Depression
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Behavioral Symptoms
Amphetamine
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013