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Bone NeoplasmBAGvsTCPNCT00841152

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

An observational study of Bone Neoplasm, run by Turku University Hospital at 5 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Neoplasm
What is being tested?
Bioactive glass, Beta-tricalcium phosphate (ChronOs) and Autograft
How many people
120 participants
Where
5 sitesFinland
Study dates
Mar 2009to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Finland5 sites

  • Helsinki University Hospital

    Helsinki, 00029

  • Kuopio University Hospital

    Kuopio, 70211

  • Oulu University Hospital

    Oulu, 90220

  • Tampere University Hsopital

    Tampere, 33521

  • Turku University Central Hospital

    Turku, 20520

Other trials in Finland

About this study

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

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.

Read the 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.

Conditions
Bone Neoplasm
Being tested
Bioactive glass, Beta-tricalcium phosphate (ChronOs), Autograft, Allograft (frozen femoral head)
Keywords
Bone tumors, Surgery, Bone graft substitutes, Bioactive glass, Bioceramics, Bone autograft, Bone allograft
Medical subject headings
Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioactive glassDevice

    Also called Bonalive (Vivoxid Ltd, Turku, Finland)

    Surgical implantation

  • Beta-tricalcium phosphate (ChronOs)Device

    Also called ChronOs (Synthes, Solothurn, Switzerland)

    Surgical implantation

  • AutograftProcedure or surgery

    Surgical transplantation from iliac crest

  • Allograft (frozen femoral head)Procedure or surgery

    Surgical transplantation

Study groups in NCT00841152
Study groupRoleWhat they receive
Hand lesionsStratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Receives: Device: Bioactive glass; Device: Beta-tricalcium phosphate (ChronOs); Procedure: Autograft
Long-bone lesionsStratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)
Receives: Device: Bioactive glass; Device: Beta-tricalcium phosphate (ChronOs); Procedure: Allograft (frozen femoral head)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stratum I: Hand-grip strength test

    Hand and finger grip strength measured by a standard device

    Measured: 3 months

  2. Stratum II: Healing of cortical bone window based on CT scan evaluation

    CT-evaluation of cortical defect healing

    Measured: 6 months

Secondary outcomes (7)

  1. Biomaterial incorporation assessed with radiographs

    Radiographic evaluation of bioactive glass and bone graft incorporation

    Measured: 3, 6, and 12 months

  2. Pain intensity (VAS)

    Evaluation of postoperative pain

    Measured: 3,6, and 12 months

  3. Stratum I: DASH-questionnaire

    Evaluation of patient-related outcome

    Measured: 3,6, and 12 months

  4. RAND-36

    Evaluation of patient-related outcome

    Measured: 3,6, and 12 months

  5. Surgical wound healing

    Clinical evaluation of surgical wound healing

    Measured: 0-3 months

  6. Soft tissue complications

    Clinical evaluation of soft tissue complications in the surgical area

    Measured: 0-12 months

  7. Bone complications

    Clinical and radiographic evaluation of complications of bone defect healing

    Measured: 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionFeb 2014
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00841152
Sponsor's protocol ID
139/180/2008
Acronym
BAGvsTCP
Status last verified
Mar 2021
First submitted
10 Feb 2009
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17966751

  • 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.

    PubMed 16821652

  • 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.

    PubMed 16338190

  • 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.

    PubMed 16116592

  • 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.

    PubMed 15941582

  • 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.

    PubMed 15793132

  • 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.

    PubMed 14566790

  • 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.

    PubMed 12632386

  • 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.

    PubMed 12209926

  • 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.

    PubMed 11374446

  • 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.

    PubMed 11340600

  • 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.

    PubMed 10532567

  • 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.

    PubMed 9104694

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Neoplasm, run by Turku University Hospital at 5 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stratum I: Hand-grip strength test (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00841152, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

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