Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute

Bone Neoplasm Clinical Trial

— BAGvsTCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841152
• Other study ID #: 139/180/2008
• Status: Completed
• Start date: March 2009
• Est. completion date: December 2018

Study information

• Verified date: March 2021
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasm
• Bone Neoplasms

Intervention

Device:
• Bioactive glass
Surgical implantation
• Beta-tricalcium phosphate (ChronOs)
Surgical implantation

Procedure:
• Autograft
Surgical transplantation from iliac crest
• Allograft (frozen femoral head)
Surgical transplantation

Locations

Country	Name	City	State
Finland	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

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Välimäki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stratum I: Hand-grip strength test	Hand and finger grip strength measured by a standard device	3 months
Primary	Stratum II: Healing of cortical bone window based on CT scan evaluation	CT-evaluation of cortical defect healing	6 months
Secondary	Biomaterial incorporation assessed with radiographs	Radiographic evaluation of bioactive glass and bone graft incorporation	3, 6, and 12 months
Secondary	Pain intensity (VAS)	Evaluation of postoperative pain	3,6, and 12 months
Secondary	Stratum I: DASH-questionnaire	Evaluation of patient-related outcome	3,6, and 12 months
Secondary	RAND-36	Evaluation of patient-related outcome	3,6, and 12 months
Secondary	Surgical wound healing	Clinical evaluation of surgical wound healing	0-3 months
Secondary	Soft tissue complications	Clinical evaluation of soft tissue complications in the surgical area	0-12 months
Secondary	Bone complications	Clinical and radiographic evaluation of complications of bone defect healing	0-12 months

External Links

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