Bioactive Glass Granules in Filling of Bone Defects

Bone Tumors Clinical Trial

Official title:

Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304121
• Other study ID #: VSSHP#2701/2007
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2011
• Last updated: June 15, 2011
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This a single center randomized trial. The hypothesis of the study is that the selected synthetic bone graft (bioactive glass granules, S53P4, Vivoxid Ltd, Turku, Finland) is as good as traditional autogenous or allogeneic bone grating in filling of non-traumatic bone defects. A total of 48 patients (stratified into two groups) will be included. The underlying bone disease will include common bening and semi-malign bone tumors (such as enchondroma and giant cell tumors) as well as tumor-like conditions (such as fibrous dysplasia, fibrous cortical defect, solitary bone cysts, aneurysmatic bone cyst).

Group I (n=24) will include patients with small benign bone lesions amenable to evacuation and autogenous bone grafting as standard of care. The patients will be randomized to autogenous bone grafting or bioactive glass granule filling. The follow-up examinations up to 52 weeks will include plain X-rays at 4, 26, and 52 weeks as well as MRI ad 4 and 52 weeks.

Group II (n=24) will include patients with a large bone defect. As the selection criteria, large defects have been defined to be defects which need allogeneic bone grafting. The patients will be randomized to allogeneic bone grafting or bioactive glass granule filling. The patients will be followed up to 52 weeks. The follow-up examinations will include X-rays at 4, 26 and 52 weeks as well as PET/CT imaging and MRI at 4 weeks and 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumors

Intervention

Device:
• Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Alm JJ, Frantzén JP, Moritz N, Lankinen P, Tukiainen M, Kellomäki 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. — 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

Keränen P, Koort J, Itälä A, Ylänen 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. — View Citation

Koort JK, Suokas E, Veiranto M, Mäkinen TJ, Jalava J, Törmälä 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. — 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, 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

Zhao 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological healing	The healing of bone defects will be examined by plain X-rays and MRI	52 weeks	Yes
Secondary	Clinical recovery	The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system	52 weeks	No
Secondary	PET imaging	PET imaging will be applied to measure blood flow and metabolic activity at the surgical site	52 weeks	No

External Links

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