M.Durand, J.L. Rouvillain, G. Daculsi, T. Fabre, Y.Catonne, (Nantes)
The association of TricOsTM (Macroporous Biphasic Ceramic Phosphate MBCP granules) and the fibrin sealant FS VH S/D 4 (ARTISSTM, Baxter), 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™ associated with a fibrin sealant in regeneration of functional bone.
A clinical study design was set up as an exploratory prospective French multicentric phase II study sponsored by INSERM. The application was the TOV (Tibial Osteotomy of Valgisation) using osteosynthesis and bone substitute: TricOs™ 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.
As for clinical trial, 14 patients are today included in the study: 3 indesirables events were reported not related to the Biomlaterials. This paper presentS the first results obtained from X-ray imaging during follow up and first histological analysis.