NCT00841152

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

4.9 years

First QC Date

February 10, 2009

Last Update Submit

March 12, 2021

Conditions

Bone Neoplasm

Keywords

Bone tumorsSurgeryBone graft substitutesBioactive glassBioceramicsBone autograftBone allograft

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (7)

  • Biomaterial incorporation assessed with radiographs

    3, 6, and 12 months

  • Pain intensity (VAS)

    3,6, and 12 months

  • Stratum I: DASH-questionnaire

    3,6, and 12 months

  • RAND-36

    3,6, and 12 months

  • Surgical wound healing

    0-3 months

  • +2 more secondary outcomes

Study Arms (2)

Hand lesions

Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)

Device: Bioactive glassDevice: Beta-tricalcium phosphate (ChronOs)Procedure: Autograft

Long-bone lesions

Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)

Device: Bioactive glassDevice: Beta-tricalcium phosphate (ChronOs)Procedure: Allograft (frozen femoral head)

Interventions

Bioactive glassDEVICE

Surgical implantation

Also known as: Bonalive (Vivoxid Ltd, Turku, Finland)
Hand lesionsLong-bone lesions
Beta-tricalcium phosphate (ChronOs)DEVICE

Surgical implantation

Also known as: ChronOs (Synthes, Solothurn, Switzerland)
Hand lesionsLong-bone lesions
AutograftPROCEDURE

Surgical transplantation from iliac crest

Hand lesions
Allograft (frozen femoral head)PROCEDURE

Surgical transplantation

Long-bone lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

Tampere University Hsopital

Tampere, 33521, Finland

Location

Turku University Central Hospital

Turku, 20520, Finland

Location

Related Publications (13)

  • 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

  • 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

  • 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.

    PMID: 16116592BACKGROUND

  • 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.

    PMID: 15941582BACKGROUND

  • 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.

    PMID: 15793132BACKGROUND

  • 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.

    PMID: 14566790BACKGROUND

  • 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.

    PMID: 12632386BACKGROUND

  • 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.

    PMID: 12209926BACKGROUND

  • 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.

    PMID: 11374446BACKGROUND

  • 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.

    PMID: 11340600BACKGROUND

  • 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.

    PMID: 10532567BACKGROUND

  • 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.

    PMID: 9104694BACKGROUND

Related Links

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Transplantation, AutologousTransplantation, Homologous

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Hannu T Aro, MD, PhD

    Turku University Central Hospital and University of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2014

Study Completion

December 1, 2018

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

FI(5)