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Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects


Phase 4
18 Years
N/A
Not Enrolling
Both
Bone Tumors

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Trial Information

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
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.


Inclusion Criteria:



- benign bone tumor or tumor-like condition

- age 18 years or more

- signed informed consent

Exclusion Criteria:

- a history of malignancy

- a medication affecting bone metabolism

- any device (such as pace maker) as contraindication for MRI imaging

- gravidity

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Radiological healing

Outcome Description:

The healing of bone defects will be examined by plain X-rays and MRI

Outcome Time Frame:

52 weeks

Safety Issue:

Yes

Principal Investigator

Hannu T Aro, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Turku University Hospital

Authority:

Finland: Finnish Medicines Agency

Study ID:

VSSHP#2701/2007

NCT ID:

NCT01304121

Start Date:

October 2006

Completion Date:

December 2010

Related Keywords:

  • Bone Tumors
  • Bone tumors
  • Bioactive glass
  • Autogenous bone grafting
  • Allogeneic bone grafting
  • PET imaging
  • Bone Neoplasms

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