JL Rouvillain, G Daculsi, Y Catonne, D Chauveaux, T Fabre, JM N’Guyen, Pelé, M Moinard , M Bagot d’Arc , M Durand
(Fort de France, Nantes, Bordeaux)
The association of TricOsTM (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™ associated with a fibrin sealant in regeneration of functional bone. The pre-clinical tests have been previously 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. The application was the HTO (High Tibial Valgus Osteotomy) using osteosynthesis and bone substitute (BS) for filling the space created. The follow up was 13 months with safety checks, clinical assessments, high-sensitivity X-ray, and CT-scan imaging. A bone sample was collected from the reconstructed area at 12 months, during the osteosynthesis material removal surgery. The principal criterion was CT-scan imaging performed 12 months after HTO surgery, before material removal, to assess qualitative and quantitative bone reconstruction. 13 patients with stage I gonarthrosis have been included in the study. This clinical follow up revealed only one case of loss of correction. X-ray and CT-scan imaging realized during the follow up indicated a progressive disappearance of the peripheric radiolucent area and a decrease of the radiopacity of the implanted area due to bioceramic resorption and bone ingrowth at the expense of the implant.
Histological analysis revealed BS large resorption and bone ingrowth both into the pores and at the expense of the bioceramic. Polarised light microscopy confirmed bone architecture with trabecular and/or dense lamellar bone growth at the expense of the wedge implants. X-Ray and micro CT scan revealed a well organised and mineralised structure in the newly-formed bone.
The present study shows that Micro Macroporous Biphasic Calcium Phosphate granules and fibrin sealant in combination with an osteosynthesis plate is a safe and efficient surgical technique for HTO