A Phase 4 interventional study of Bioactive glass (SP53P4) in Bone Tumors, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-16.
Sponsored by Turku University Hospital · Phase 4, Interventional, and Treatment
This is a randomized clinical trial that will be carried out to examine the use of bioactive glass granules (S53P4) as bone graft substitute in filling small and large bone defects as compared with autogenous and allogeneic bone grafting, respectively.
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 weeks.
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.
322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 218 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Resorbable bioactive glass granules
Device: Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)
Also known as: Abmin (trademark), Vioxid Ltd
Radiological healing
The healing of bone defects will be examined by plain X-rays and MRI
Time frame: 52 weeks
Clinical recovery
The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system
Time frame: 52 weeks
PET imaging
PET imaging will be applied to measure blood flow and metabolic activity at the surgical site
Time frame: 52 weeks
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Turku University Hospital