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Bioactive Glass Granules in Filling of Bone Defects

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ClinicalTrials.gov Identifier: NCT01304121
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bone Tumors Device: Bioactive glass (SP53P4) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects
Study Start Date : October 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bioactive glass
Resorbable bioactive glass granules
Device: Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)
Other Name: Abmin (trademark), Vioxid Ltd




Primary Outcome Measures :
  1. Radiological healing [ Time Frame: 52 weeks ]
    The healing of bone defects will be examined by plain X-rays and MRI


Secondary Outcome Measures :
  1. 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

  2. PET imaging [ Time Frame: 52 weeks ]
    PET imaging will be applied to measure blood flow and metabolic activity at the surgical site



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304121


Locations
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Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Hannu T Aro, MD, PhD Turku University Hospital
Additional Information:
Publications:

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Responsible Party: Hannu T Aro, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01304121    
Other Study ID Numbers: VSSHP#2701/2007
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011
Keywords provided by Turku University Hospital:
Bone tumors
Bioactive glass
Autogenous bone grafting
Allogeneic bone grafting
PET imaging
Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases