Clinical trial · Interventional
Bioactive Glass Granules in Filling of Bone Defects
Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects
NCT01304121CI-TRIAL-00005032completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Tumors | Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioactive glass (SP53P4) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bioactive glass
- description
- Resorbable bioactive glass granules
- interventionNames
- Device: Bioactive glass (SP53P4)
Primary outcomes (1)
- measure
- Radiological healing
- timeFrame
- 52 weeks
- description
- The healing of bone defects will be examined by plain X-rays and MRI
Secondary outcomes (2)
- measure
- Clinical recovery
- timeFrame
- 52 weeks
- description
- The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDValimaki 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. PMID 16821652
- BACKGROUNDValimaki 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. PMID 16338190
- BACKGROUNDKeranen 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. PMID 17966751
- BACKGROUNDZhao 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. PMID 18356122
- BACKGROUNDKoort 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. PMID 16736479
- BACKGROUNDAlm 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. PMID 20229522
- BACKGROUNDKeranen 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.