Papers by Author: Marlene Durand

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Authors: Daculsi Guy, Jean Louis Rouvillain, Thierry Fabre, Yves Catonné, Maurice Bagot d'Arc, Jean Michel N'Guyen, Marlene Durand
Abstract: The association of Micro Macroporous Biphasic Calcium Phosphate granules and t fibrin sealant has been developed to answer a challenging request of orthopaedic surgeons: a biocompatible, osteogenic, mouldable, and self-hardening bone substitute able to fill bone defects. The aim of this study was the evaluation of the performance and safety of the bioactive composite 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 HTVO (Tibial Osteotomy of Valgisation) using osteosynthesis and bone substitute (BS) for filling the space created. The follow up was 12 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. 13 patients with stage I gonarthrosis have been included in the study. This clinical follow up revealed only one case of correction loss. X-ray and CT-scan imaging indicated a progressive disappearance of the peripheric radioluency 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. X-Ray and micro CT scan revealed a well organised and mineralised structure in the newly-formed bone.
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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: G. Daculsi, Marlene Durand, O. Hauger, Seris Elodie, Pascal Borget, Racquel Z. LeGeros, J.C. Le Huec
Abstract: Due to the lack of macroporosity in current available Calcium Phosphate cement used in osteoarticular surgery, Micro and Macroporous Biphasic CaP Cement (MCPC™) was developed. The MCPC™ concept was the association of a settable and a fast resorbable matrix and a sieved fraction of microporous biphasic calcium phosphate (BCP) granules, recognized for the high osteoconductive and osteogenic properties. During the resorption of the matrix, a porous structure is created and the osteoconductive effect of the granules promotes the bone ingrowth. A goat preclinical study was realized to evaluate the efficacy of MCPC™ for C3 and C4 vertebral body filling defects during 6 months. Bone remodelling was evidenced demonstrating bone ingrowth at the expense of the cement and surrounding the residual BCP granules. Bone trabeculae were observed coming from the spongious bone to the implant site. Human vertebral body filling cases demonstrated the biocompatibility and the safety of MCPC™ for bone reconstruction. Results of this study demonstrated the importance of special combination of calcium phosphate granules in the MCPC™ to provide macroporosity and scaffolding for newly formed bone.
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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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