Clinical trial · Observational
Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute
A National, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute in Filling of Contained Bone Defects
NCT00841152CI-TRIAL-00050665BAGvsTCPcompletedClinicalTrials.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 study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Based on the investigators' previous preclinical research and an ongoing single-center randomized clinical trial on bioactive glass filling, the investigators expect BAG filling to be more efficient compared to TCP in promotion of defect healing and functional recovery after surgery.
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 Neoplasm | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allograft (frozen femoral head) | Procedure | — | UNRESOLVED |
| Autograft | Procedure | — | UNRESOLVED |
| Beta-tricalcium phosphate (ChronOs) | Device | — | UNRESOLVED |
| Bioactive glass | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hand lesions
- description
- Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
- interventionNames
- Device: Bioactive glass
- Device: Beta-tricalcium phosphate (ChronOs)
- Procedure: Autograft
- label
- Long-bone lesions
- description
- Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)
- interventionNames
- Device: Bioactive glass
- Device: Beta-tricalcium phosphate (ChronOs)
- Procedure: Allograft (frozen femoral head)
Primary outcomes (2)
- measure
- Stratum I: Hand-grip strength test
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling * Pathological fractures of patients in Stratum I are treated by means of conservative treatment for three months before tumor surgery Exclusion Criteria: * History of acute or chronic local infection * 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
References
Publications (13)
- 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
- 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
- BACKGROUNDValimaki 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. PMID 16116592
- BACKGROUNDValimaki 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. PMID 15941582
- BACKGROUNDKoort 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. PMID 15793132
- BACKGROUNDItala 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.