Comparison of Bioactive Glass and Beeta-Tricalcium Phosphate as Bone Graft Substitute
Summary
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. Based on the investigators' previous preclinical research and an ongoing single-center RCT 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.
Description
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Conditions
Bone Neoplasm
Intervention
Bioactive glass granules (Bonalive), Beeta-tricalcium phosphate (ChronOs), Autograft, Allograft (frozen femoral head)
Location
Helsinki University Hospital
Helsinki
Finland
00029
Status
Recruiting
Source
Turku University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00841152
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bone Cements
Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Synthetic resins are commonly used as cements. A mixture of monocalcium phosphate, monohydrate, alpha-tricalcium phosphate, and calcium carbonate with a sodium phosphate solution is also a useful bone paste.
Compomers
Composite materials composed of an ion-leachable glass embedded in a polymeric matrix. They differ from GLASS IONOMER CEMENTS in that partially silanized glass particles are used to provide a direct bond to the resin matrix and the matrix is primarily formed by a light-activated, radical polymerization reaction.
Cermet Cements
Fluoride-releasing restorative materials made by the sintering of metal (usually silver) particles to glass ionomer powder. Glass ionomers are fluoride-releasing cements that are not very durable. Sintering of the metal particles is a means of improving those physical properties that will make the glass ionomer cement more durable.
Transketolase
An enzyme of the transferase class that catalyzes the conversion of sedoheptulose 7-phosphate and D-glyceraldehyde 3-phosphate to D-ribose 5-phosphate and D-xylulose 5-phosphate in the PENTOSE PHOSPHATE PATHWAY. (Dorland, 27th ed) EC 2.2.1.1.
Transaldolase
An enzyme of the transferase class that catalyzes the reaction sedoheptulose 7-phosphate and D-glyceraldehyde 3-phosphate to yield D-erythrose 4-phosphate and D-fructose phosphate in the PENTOSE PHOSPHATE PATHWAY. (Dorland, 27th ed) EC 2.2.1.2.
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