BAGvsTCP: Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hand lesions Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate) |
Device: Bioactive glass
Surgical implantation
Other Names:
Device: Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Other Names:
Procedure: Autograft
Surgical transplantation from iliac crest
|
| Long-bone lesions Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft) |
Device: Bioactive glass
Surgical implantation
Other Names:
Device: Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Other Names:
Procedure: Allograft (frozen femoral head)
Surgical transplantation
|
Outcome Measures
Primary Outcome Measures
- Stratum I: Hand-grip strength test [3 months]
Hand and finger grip strength measured by a standard device
- Stratum II: Healing of cortical bone window based on CT scan evaluation [6 months]
CT-evaluation of cortical defect healing
Secondary Outcome Measures
- Biomaterial incorporation assessed with radiographs [3, 6, and 12 months]
Radiographic evaluation of bioactive glass and bone graft incorporation
- Pain intensity (VAS) [3,6, and 12 months]
Evaluation of postoperative pain
- Stratum I: DASH-questionnaire [3,6, and 12 months]
Evaluation of patient-related outcome
- RAND-36 [3,6, and 12 months]
Evaluation of patient-related outcome
- Surgical wound healing [0-3 months]
Clinical evaluation of surgical wound healing
- Soft tissue complications [0-12 months]
Clinical evaluation of soft tissue complications in the surgical area
- Bone complications [0-12 months]
Clinical and radiographic evaluation of complications of bone defect healing
Eligibility Criteria
Criteria
Inclusion Criteria:
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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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Pathological fractures of patients in Stratum I are treated by means of conservative treatment for three months before tumor surgery
Exclusion Criteria:
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History of acute or chronic local infection
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History of malignancy (excluding carcinoma basocellular) within past 5 years
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A history of local radiotherapy
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A known metabolic skeletal disease (such as osteoporosis, Paget's disease or osteomalacia)
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Medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)
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Any plans to use phenol or other chemical/thermal method of local tumor control
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Pregnancy
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsinki University Hospital | Helsinki | Finland | 00029 | |
| 2 | Kuopio University Hospital | Kuopio | Finland | 70211 | |
| 3 | Oulu University Hospital | Oulu | Finland | 90220 | |
| 4 | Tampere University Hsopital | Tampere | Finland | 33521 | |
| 5 | Turku University Central Hospital | Turku | Finland | 20520 |
Sponsors and Collaborators
- Turku University Hospital
Investigators
- Principal Investigator: Hannu T Aro, MD, PhD, Turku University Central Hospital and University of Turku
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Gao T, Aro HT, Ylänen 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.
- Itälä A, Koort J, Ylänen 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.
- Itälä A, Nordström EG, Ylänen H, Aro HT, Hupa M. Creation of microrough surface on sintered bioactive glass microspheres. J Biomed Mater Res. 2001 Aug;56(2):282-8.
- Itälä A, Välimäki VV, Kiviranta R, Ylänen 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.
- Itälä A, Ylänen 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.
- Keränen P, Itälä 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.
- Koort JK, Mäkinen TJ, Suokas E, Veiranto M, Jalava J, Knuuti J, Törmälä 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.
- Välimäki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. Review.
- Välimäki 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.
- Välimäki 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. Epub 2005 Dec 9.
- Välimäki 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.
- Virolainen P, Heikkilä 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.
- Ylänen 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.
- 139/180/2008