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CompletedNCT00841152BAGvsTCPUpdated Mar 16, 2021

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

An observational study in Bone Neoplasm, sponsored by Turku University Hospital. Completed at 5 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Turku University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Bone Neoplasm

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Keywords

  • Bone tumors
  • Surgery
  • Bone graft substitutes
  • Bioactive glass
  • Bioceramics
  • Bone autograft
  • Bone allograft
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In context

Bone Neoplasms

322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's enrollment of 120 is above the median of 75 across 93 observational studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Hand lesions

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

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

  • Long-bone lesions

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

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

Interventions

  • DeviceBioactive glass

    Surgical implantation

    Also known as: Bonalive (Vivoxid Ltd, Turku, Finland)

  • DeviceBeta-tricalcium phosphate (ChronOs)

    Surgical implantation

    Also known as: ChronOs (Synthes, Solothurn, Switzerland)

  • ProcedureAutograft

    Surgical transplantation from iliac crest

  • ProcedureAllograft (frozen femoral head)

    Surgical transplantation

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What researchers measure

Primary outcomes

  1. Stratum I: Hand-grip strength test

    Hand and finger grip strength measured by a standard device

    Time frame: 3 months

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

    CT-evaluation of cortical defect healing

    Time frame: 6 months

Secondary outcomes

  1. Biomaterial incorporation assessed with radiographs

    Radiographic evaluation of bioactive glass and bone graft incorporation

    Time frame: 3, 6, and 12 months

  2. Pain intensity (VAS)

    Evaluation of postoperative pain

    Time frame: 3,6, and 12 months

  3. Stratum I: DASH-questionnaire

    Evaluation of patient-related outcome

    Time frame: 3,6, and 12 months

  4. RAND-36

    Evaluation of patient-related outcome

    Time frame: 3,6, and 12 months

  5. Surgical wound healing

    Clinical evaluation of surgical wound healing

    Time frame: 0-3 months

  6. Soft tissue complications

    Clinical evaluation of soft tissue complications in the surgical area

    Time frame: 0-12 months

  7. Bone complications

    Clinical and radiographic evaluation of complications of bone defect healing

    Time frame: 0-12 months

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Study locations

5 sites
  • Helsinki University Hospital
    Helsinki, 00029, Finland
  • Kuopio University Hospital
    Kuopio, 70211, Finland
  • Oulu University Hospital
    Oulu, 90220, Finland
  • Tampere University Hsopital
    Tampere, 33521, Finland
  • Turku University Central Hospital
    Turku, 20520, Finland
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00841152
Lead sponsor
Turku University Hospital
Responsible party
Sponsor
First posted
Feb 11, 2009
Start date
Mar 2009
Primary completion
Feb 2014
Completion
Dec 2018
Last update
Mar 16, 2021

Study contacts

Hannu T Aro, MD, PhD
principal investigator · Turku University Central Hospital and University of Turku

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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