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NCT00935870 Clinical Trial

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

Spinal Fusion Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00935870
Other study ID # 1005-3
Secondary ID
Status Completed
Phase N/A
First received July 7, 2009
Last updated July 8, 2009
Start date January 2008
Est. completion date February 2009

Study information
Verified date July 2009
Source Vivoxid Ltd
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date February 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Vivoxid Ltd

Country where clinical trial is conducted

Finland, 

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