TricOs~(TM) and Fibrin Sealant Combined for Bone Defect Filling: From Pre-Clinical Tests to Prospective Clinical Study. Preliminary human data

摘要

The association of TricOs~(TM) (Macroporous Biphasic Ceramic Phosphate MBCP granules) and the fibrin sealant FS VH S/D 4, has been developed to answer a challenging request of orthopaedic surgeons: a biocompatible, osteogenic, mouldable, and self-hardening bone substitute able to fill randomly shaped bone defects. The aims of this study was the evaluation of the performance and safety of the bioactive bone substitute TricOs~(TM) associated with a fibrin sealant in regeneration of functional bone. The pre-clinical tests were conducted to optimize MBCP granules size and ratio MBCP-FS VH S/D 4 (sheep maxillary sinus grafting, femoral epiphysis defect in rabbits, long bone defects in sheep). A clinical study design was set up as an exploratory prospective French multicentric phase II study sponsored by INSERM (Institut National de la Sante et de la Recherche Medicale). The application was the TOV (Tibial Osteotomy of Valgisation) using osteosynthesis and bone substitute: TricOs~(TM) mixed with the fibrin sealant (FS VH S/D 4) for filling the space created. The follow up is 13 months with safety checks, clinical assessments, high-sensitivity X-ray, and CT-scan imaging. A bone sample will be collected from the reconstructed area at 12 months, during the osteosynthesis material removal surgery. The principal criterion is CT-scan imaging performed 12 months after TOV surgery, before material removal, to assess qualitative and quantitative bone reconstruction. Animals' studies demonstrate that the biomaterial is safe to use and shows osteoconductive properties, granules resorption and bone ingrowth at the expenses of the implants. As for clinical trial, 7 patients are today included in the study: This paper present the first results obtained from X-ray imaging during follow up.