A National, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Bioactive Glass and Beeta-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 beeta-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 SOC controls.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Stratum I: Hand-grip strength test
3 months
No
Hannu T Aro, MD, PhD
Principal Investigator
Turku University Central Hospital and University of Turku
Finland: Finnish Medicines Agency
139/180/2008
NCT00841152
March 2009
December 2014
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