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

This study is currently recruiting participants.
Verified February 2014 by Turku University Hospital
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT00841152
First received: February 10, 2009
Last updated: February 14, 2014
Last verified: February 2014

February 10, 2009
February 14, 2014
March 2009
February 2014   (final data collection date for primary outcome measure)
  • Stratum I: Hand-grip strength test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Stratum II: Healing of cortical bone window based on CT scan evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841152 on ClinicalTrials.gov Archive Site
  • Biomaterial incorporation assessed with radiographs [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Pain intensity (VAS) [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: Yes ]
  • Stratum I: DASH-questionnaire [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
  • RAND-36 [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
  • Surgical wound healing [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
  • Soft tissue complications [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
  • Bone complications [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
  • Biomaterial incorporation assessed with radiographs [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Pain intensity (VAS) [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: Yes ]
  • Stratum I: DASH-questionnaire [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
  • Surgical wound healing [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
  • Soft tissue complications [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
  • Bone complications [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Bone Neoplasm
  • 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
  • Procedure: Allograft (frozen femoral head)
    Surgical transplantation
  • Hand lesions
    Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
    Interventions:
    • 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)
    Interventions:
    • Device: Bioactive glass
    • Device: Beta-tricalcium phosphate (ChronOs)
    • Procedure: Allograft (frozen femoral head)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Hannu T Aro, MD,PhD +358-40-3537644 hannu.aro@utu.fi
Contact: Satu J Timlin, RN +358-50-4381824 satu.timlin@utu.fi
Finland
 
NCT00841152
139/180/2008
No
Turku University Hospital
Turku University Hospital
Not Provided
Principal Investigator: Hannu T Aro, MD, PhD Turku University Central Hospital and University of Turku
Turku University Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP