Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute
NCT ID: NCT00841152
Last Updated: 2021-03-16
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
120 participants
OBSERVATIONAL
2009-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hand lesions
Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Bioactive glass
Surgical implantation
Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Autograft
Surgical transplantation from iliac crest
Long-bone lesions
Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)
Bioactive glass
Surgical implantation
Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Allograft (frozen femoral head)
Surgical transplantation
Interventions
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Bioactive glass
Surgical implantation
Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Autograft
Surgical transplantation from iliac crest
Allograft (frozen femoral head)
Surgical transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathological fractures of patients in Stratum I are treated by means of conservative treatment for three months before tumor surgery
Exclusion Criteria
* History of malignancy (excluding carcinoma basocellular) within past 5 years
* A history of local radiotherapy
* A known metabolic skeletal disease (such as osteoporosis, Paget's disease or osteomalacia)
* Medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)
* Any plans to use phenol or other chemical/thermal method of local tumor control
* Pregnancy
* Any other condition that in the judgment of the investigator, would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results
18 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Hannu T Aro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Central Hospital and University of Turku
Locations
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Helsinki University Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hsopital
Tampere, , Finland
Turku University Central Hospital
Turku, , Finland
Countries
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References
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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.
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.
Valimaki VV, Yrjans JJ, Vuorio E, Aro HT. Combined effect of BMP-2 gene transfer and bioactive glass microspheres on enhancement of new bone formation. J Biomed Mater Res A. 2005 Dec 1;75(3):501-9. doi: 10.1002/jbm.a.30236.
Valimaki VV, Moritz N, Yrjans JJ, Dalstra M, Aro HT. Peripheral quantitative computed tomography in evaluation of bioactive glass incorporation with bone. Biomaterials. 2005 Nov;26(33):6693-703. doi: 10.1016/j.biomaterials.2005.04.033.
Koort JK, Makinen TJ, Suokas E, Veiranto M, Jalava J, Knuuti J, Tormala P, Aro HT. Efficacy of ciprofloxacin-releasing bioabsorbable osteoconductive bone defect filler for treatment of experimental osteomyelitis due to Staphylococcus aureus. Antimicrob Agents Chemother. 2005 Apr;49(4):1502-8. doi: 10.1128/AAC.49.4.1502-1508.2005.
Itala A, Koort J, Ylanen HO, Hupa M, Aro HT. Biologic significance of surface microroughing in bone incorporation of porous bioactive glass implants. J Biomed Mater Res A. 2003 Nov 1;67(2):496-503. doi: 10.1002/jbm.a.10501.
Itala A, Valimaki VV, Kiviranta R, Ylanen HO, Hupa M, Vuorio E, Aro HT. Molecular biologic comparison of new bone formation and resorption on microrough and smooth bioactive glass microspheres. J Biomed Mater Res B Appl Biomater. 2003 Apr 15;65(1):163-70. doi: 10.1002/jbm.b.10529.
Itala A, Ylanen HO, Yrjans J, Heino T, Hentunen T, Hupa M, Aro HT. Characterization of microrough bioactive glass surface: surface reactions and osteoblast responses in vitro. J Biomed Mater Res. 2002 Dec 5;62(3):404-11. doi: 10.1002/jbm.10273.
Gao T, Aro HT, Ylanen H, Vuorio E. Silica-based bioactive glasses modulate expression of bone morphogenetic protein-2 mRNA in Saos-2 osteoblasts in vitro. Biomaterials. 2001 Jun;22(12):1475-83. doi: 10.1016/s0142-9612(00)00288-x.
Itala A, Nordstrom EG, Ylanen H, Aro HT, Hupa M. Creation of microrough surface on sintered bioactive glass microspheres. J Biomed Mater Res. 2001 Aug;56(2):282-8. doi: 10.1002/1097-4636(200108)56:23.0.co;2-5.
Ylanen HO, Helminen T, Helminen A, Rantakokko J, Karlsson KH, Aro HT. Porous bioactive glass matrix in reconstruction of articular osteochondral defects. Ann Chir Gynaecol. 1999;88(3):237-45.
Virolainen P, Heikkila J, Yli-Urpo A, Vuorio E, Aro HT. Histomorphometric and molecular biologic comparison of bioactive glass granules and autogenous bone grafts in augmentation of bone defect healing. J Biomed Mater Res. 1997 Apr;35(1):9-17. doi: 10.1002/(sici)1097-4636(199704)35:13.0.co;2-s.
Related Links
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Home site of the principal research center
Other Identifiers
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139/180/2008
Identifier Type: -
Identifier Source: org_study_id
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