NCT01304121

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

4.2 years

First QC Date

February 21, 2011

Last Update Submit

June 15, 2011

Conditions

Bone Tumors

Keywords

Bone tumorsBioactive glassAutogenous bone graftingAllogeneic bone graftingPET imaging

Outcome Measures

Primary Outcomes (1)

  • Radiological healing

    The healing of bone defects will be examined by plain X-rays and MRI

    52 weeks

Secondary Outcomes (2)

  • Clinical recovery

    52 weeks

  • PET imaging

    52 weeks

Study Arms (1)

Bioactive glass

EXPERIMENTAL

Resorbable bioactive glass granules

Device: Bioactive glass (SP53P4)

Interventions

Bioactive glass (SP53P4)DEVICE

Commercial resorbable bone graft substitute (Vioxid Ltd)

Also known as: Abmin (trademark), Vioxid Ltd
Bioactive glass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • benign bone tumor or tumor-like condition
  • age 18 years or more
  • signed informed consent

You may not qualify if:

  • a history of malignancy
  • a medication affecting bone metabolism
  • any device (such as pace maker) as contraindication for MRI imaging
  • gravidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (7)

  • 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.

    PMID: 16821652BACKGROUND

  • 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.

    PMID: 16338190BACKGROUND

  • 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.

    PMID: 17966751BACKGROUND

  • 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.

    PMID: 18356122BACKGROUND

  • Koort JK, Suokas E, Veiranto M, Makinen TJ, Jalava J, Tormala 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. doi: 10.1002/jbm.a.30766.

    PMID: 16736479BACKGROUND

  • Alm JJ, Frantzen JP, Moritz N, Lankinen P, Tukiainen M, Kellomaki 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.

    PMID: 20229522BACKGROUND

  • Keranen P, Koort J, Itala A, Ylanen 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.

    PMID: 19437438BACKGROUND

Related Links

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Hannu T Aro, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 25, 2011

Study Start

October 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

FI(1)