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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841152
First Posted: February 11, 2009
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Turku University Hospital
  Purpose
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.

Condition Intervention
Bone Neoplasm Device: Bioactive glass Device: Beta-tricalcium phosphate (ChronOs) Procedure: Autograft Procedure: Allograft (frozen femoral head)

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Stratum I: Hand-grip strength test [ Time Frame: 3 months ]
  • Stratum II: Healing of cortical bone window based on CT scan evaluation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Biomaterial incorporation assessed with radiographs [ Time Frame: 3, 6, and 12 months ]
  • Pain intensity (VAS) [ Time Frame: 3,6, and 12 months ]
  • Stratum I: DASH-questionnaire [ Time Frame: 3,6, and 12 months ]
  • RAND-36 [ Time Frame: 3,6, and 12 months ]
  • Surgical wound healing [ Time Frame: 0-3 months ]
  • Soft tissue complications [ Time Frame: 0-12 months ]
  • Bone complications [ Time Frame: 0-12 months ]

Enrollment: 120
Actual Study Start Date: March 2009
Estimated Study Completion Date: December 2018
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hand lesions
Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Device: Bioactive glass
Surgical implantation
Other Name: Bonalive (Vivoxid Ltd, Turku, Finland)
Device: Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Other Name: ChronOs (Synthes, Solothurn, Switzerland)
Procedure: Autograft
Surgical transplantation from iliac crest
Long-bone lesions
Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)
Device: Bioactive glass
Surgical implantation
Other Name: Bonalive (Vivoxid Ltd, Turku, Finland)
Device: Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Other Name: ChronOs (Synthes, Solothurn, Switzerland)
Procedure: Allograft (frozen femoral head)
Surgical transplantation

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
Criteria

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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841152


Locations
Finland
Helsinki University Hospital
Helsinki, Finland, 00029
Kuopio University Hospital
Kuopio, Finland, 70211
Oulu University Hospital
Oulu, Finland, 90220
Tampere University Hsopital
Tampere, Finland, 33521
Turku University Central Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Hannu T Aro, MD, PhD Turku University Central Hospital and University of Turku
  More Information

Additional Information:
Publications:
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.
Välimäki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. Review.
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.
Välimäki 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.
Välimäki 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.
Koort JK, Mäkinen TJ, Suokas E, Veiranto M, Jalava J, Knuuti J, Törmälä 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.
Itälä A, Koort J, Ylänen 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.
Itälä A, Välimäki VV, Kiviranta R, Ylänen 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.
Itälä A, Ylänen 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.
Gao T, Aro HT, Ylänen 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.
Itälä A, Nordström EG, Ylänen H, Aro HT, Hupa M. Creation of microrough surface on sintered bioactive glass microspheres. J Biomed Mater Res. 2001 Aug;56(2):282-8.
Ylänen 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.
Virolainen P, Heikkilä 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.

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT00841152     History of Changes
Other Study ID Numbers: 139/180/2008
First Submitted: February 10, 2009
First Posted: February 11, 2009
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Turku University Hospital:
Bone tumors
Surgery
Bone graft substitutes
Bioactive glass
Bioceramics
Bone autograft
Bone allograft

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors


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