Papers by Author: Maryse Moinard

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Authors: Thierry Fabre, Dominique Chauveaux, Maryse Moinard, Claude Mais, Marlene Durand, Claire Pollart, G. Daculsi
Abstract: The biomaterial studied here is a composite associating a mineral phase of an intimate nanoscale melting of hydroxyapatite and beta tri calcium phosphate and an aqueous phase containing a synthetic polymer derived from cellulose HPMC (hydroxyl propyl methyl cellulose), marketed under name MBCP Gel (FDA approval, Biomatlante manufacturer). The present exploratory study aim was to study the safety of MBCP-gel, and to determine in the osseous healthy area the performance of MBCP gel. We expected to prove bone ingrowth into the osseous cavities created during drilling biopsy of the aseptic osteonecrosis of femoral head. The current results obtained in the first two patients with 1 year follow up demonstrate the resorption and bone ingrowth with trabecular bone architecture in the hole created into the femoral neck.
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Authors: Marlene Durand, Dominique Chauveaux, Maryse Moinard, Thierry Fabre, Jean Louis Rouvillain, Maurice Bagot d'Arc, G. Daculsi
Abstract: 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 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 Santé et de la Recherche Médicale). 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, highsensitivity 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.
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