Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects
This a single center randomized trial. The hypothesis of the study is that the selected
synthetic bone graft (bioactive glass granules, S53P4, Vivoxid Ltd, Turku, Finland) is as
good as traditional autogenous or allogeneic bone grating in filling of non-traumatic bone
defects. A total of 48 patients (stratified into two groups) will be included. The
underlying bone disease will include common bening and semi-malign bone tumors (such as
enchondroma and giant cell tumors) as well as tumor-like conditions (such as fibrous
dysplasia, fibrous cortical defect, solitary bone cysts, aneurysmatic bone cyst).
Group I (n=24) will include patients with small benign bone lesions amenable to evacuation
and autogenous bone grafting as standard of care. The patients will be randomized to
autogenous bone grafting or bioactive glass granule filling. The follow-up examinations up
to 52 weeks will include plain X-rays at 4, 26, and 52 weeks as well as MRI ad 4 and 52
Group II (n=24) will include patients with a large bone defect. As the selection criteria,
large defects have been defined to be defects which need allogeneic bone grafting. The
patients will be randomized to allogeneic bone grafting or bioactive glass granule filling.
The patients will be followed up to 52 weeks. The follow-up examinations will include X-rays
at 4, 26 and 52 weeks as well as PET/CT imaging and MRI at 4 weeks and 52 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
The healing of bone defects will be examined by plain X-rays and MRI
Hannu T Aro, MD, PhD
Turku University Hospital
Finland: Finnish Medicines Agency