Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2006-10-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bioactive glass
Resorbable bioactive glass granules
Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)
Interventions
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Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18 years or more
* signed informed consent
Exclusion Criteria
* a medication affecting bone metabolism
* any device (such as pace maker) as contraindication for MRI imaging
* gravidity
18 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Turku University Hospital
Principal Investigators
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Hannu T Aro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Turku University Hospital
Turku, , Finland
Countries
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References
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Valimaki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. doi: 10.1177/145749690609500204.
Valimaki VV, Moritz N, Yrjans JJ, Vuorio E, Aro HT. Effect of zoledronic acid on incorporation of a bioceramic bone graft substitute. Bone. 2006 Mar;38(3):432-43. doi: 10.1016/j.bone.2005.09.016. Epub 2005 Dec 9.
Keranen P, Itala A, Koort J, Kohonen I, Dalstra M, Kommonen B, Aro HT. Bioactive glass granules as extender of autogenous bone grafting in cementless intercalary implant of the canine femur. Scand J Surg. 2007;96(3):243-51. doi: 10.1177/145749690709600310.
Zhao D, Moritz N, Vedel E, Hupa L, Aro HT. Mechanical verification of soft-tissue attachment on bioactive glasses and titanium implants. Acta Biomater. 2008 Jul;4(4):1118-22. doi: 10.1016/j.actbio.2008.02.012. Epub 2008 Mar 4.
Koort JK, Suokas E, Veiranto M, Makinen TJ, Jalava J, Tormala P, Aro HT. In vitro and in vivo testing of bioabsorbable antibiotic containing bone filler for osteomyelitis treatment. J Biomed Mater Res A. 2006 Sep 1;78(3):532-40. doi: 10.1002/jbm.a.30766.
Alm JJ, Frantzen JP, Moritz N, Lankinen P, Tukiainen M, Kellomaki M, Aro HT. In vivo testing of a biodegradable woven fabric made of bioactive glass fibers and PLGA80--a pilot study in the rabbit. J Biomed Mater Res B Appl Biomater. 2010 May;93(2):573-80. doi: 10.1002/jbm.b.31618.
Keranen P, Koort J, Itala A, Ylanen H, Dalstra M, Hupa M, Kommonen B, Aro HT. Bioceramic inlays do not improve mechanical incorporation of grit-blasted titanium stems in the proximal sheep femur. J Biomed Mater Res A. 2010 Mar 15;92(4):1578-86. doi: 10.1002/jbm.a.32494.
Related Links
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Homepage of the clinical research unit
Other Identifiers
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VSSHP#2701/2007
Identifier Type: -
Identifier Source: org_study_id
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