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

Completed

• Conditions: Depressed Lateral Condyle Fracture; Benign Bone Tumour Cavity; Spinal Fusion
• Interventions: Device: Bioactive glass and/or autogenous bone

• Registration Number: NCT00935870
• Lead Sponsor: Vivoxid Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Study Completion: 2009-02
• Status Verified: 2009-07
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-08
• Last Update Submitted: 2009-07-08
• Study First Posted: 2009-07-09
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Bioactive glass and/or autogenous bone	DEPRESSED LATERAL CONDYLE FRACTURE
B	Bioactive glass and/or autogenous bone	BENIGN BONE TUMOR
C	Bioactive glass and/or autogenous bone	SPINAL FUSION

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland