Bioactive Glass Granules in Filling of Bone Defects
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects|
- Radiological healing [ Time Frame: 52 weeks ]The healing of bone defects will be examined by plain X-rays and MRI
- Clinical recovery [ Time Frame: 52 weeks ]The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system
- PET imaging [ Time Frame: 52 weeks ]PET imaging will be applied to measure blood flow and metabolic activity at the surgical site
|Study Start Date:||October 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Bioactive glass
Resorbable bioactive glass granules
Device: Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)
Other Name: Abmin (trademark), Vioxid Ltd
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304121
|Turku University Hospital|
|Turku, Finland, 20520|
|Principal Investigator:||Hannu T Aro, MD, PhD||Turku University Hospital|