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

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ClinicalTrials.gov Identifier: NCT00841152
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

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.

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

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.

Study Type : Observational
Actual Enrollment : 120 participants
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
Actual Study Start Date : March 2009
Actual Primary Completion Date : February 2014
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



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

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


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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

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

Additional Information:
Publications:

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT00841152     History of Changes
Other Study ID Numbers: 139/180/2008
First Posted: February 11, 2009    Key Record Dates
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