Bioactive Glass Granules in Filling of Bone Defects

Phase 4

Completed

• Conditions: Bone Tumors
• Interventions: Device: Bioactive glass (SP53P4)

• Registration Number: NCT01304121
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioactive glass	Bioactive glass (SP53P4)	Resorbable bioactive glass granules

Primary Outcome Measures

Name	Time	Method
Radiological healing	52 weeks	The healing of bone defects will be examined by plain X-rays and MRI

Secondary Outcome Measures

Name	Time	Method
Clinical recovery	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	52 weeks	PET imaging will be applied to measure blood flow and metabolic activity at the surgical site

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland