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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.
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. Small metacarpal and phalangeal enchondromas (Stratum I) and large long-bone lesions (Stratum II) will be evaluated separately. Aside with the head-to-head comparison of the two synthetic bone graft substitutes, autologous bone graft (Stratum I) and allogeneic bone graft (Stratum II) will be used as the standard of care controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand lesions | Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate) |
| |
| Long-bone lesions | Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioactive glass | Device | Surgical implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stratum I: Hand-grip strength test | Hand and finger grip strength measured by a standard device | 3 months |
| Stratum II: Healing of cortical bone window based on CT scan evaluation | CT-evaluation of cortical defect healing | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomaterial incorporation assessed with radiographs | Radiographic evaluation of bioactive glass and bone graft incorporation | 3, 6, and 12 months |
| Pain intensity (VAS) | Evaluation of postoperative pain |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling.
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| Name | Affiliation | Role |
|---|---|---|
| Hannu T Aro, MD, PhD | Turku University Central Hospital and University of Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland | |||
| Kuopio University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17966751 | Background | 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. | |
| 16821652 | Background | 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. |
| Label | URL |
|---|---|
| Home site of the principal research center | View source |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Beta-tricalcium phosphate (ChronOs) | Device | Surgical implantation |
|
|
| Autograft | Procedure | Surgical transplantation from iliac crest |
|
| Allograft (frozen femoral head) | Procedure | Surgical transplantation |
|
| 3,6, and 12 months |
| Stratum I: DASH-questionnaire | Evaluation of patient-related outcome | 3,6, and 12 months |
| RAND-36 | Evaluation of patient-related outcome | 3,6, and 12 months |
| Surgical wound healing | Clinical evaluation of surgical wound healing | 0-3 months |
| Soft tissue complications | Clinical evaluation of soft tissue complications in the surgical area | 0-12 months |
| Bone complications | Clinical and radiographic evaluation of complications of bone defect healing | 0-12 months |
| Kuopio |
| 70211 |
| Finland |
| Oulu University Hospital | Oulu | 90220 | Finland |
| Tampere University Hsopital | Tampere | 33521 | Finland |
| Turku University Central Hospital | Turku | 20520 | Finland |
| 16338190 | Background | 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. |
| 16116592 | Background | 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. |
| 15941582 | Background | 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. |
| 15793132 | Background | 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. |
| 14566790 | Background | 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. |
| 12632386 | Background | 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. |
| 12209926 | Background | 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. |
| 11374446 | Background | 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. |
| 11340600 | Background | 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. |
| 10532567 | Background | 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. |
| 9104694 | Background | 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. |