Bioceramic and Fibrin Sealant in High Tibial Valgus Osteotomy: Prospective Clinical Study

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.

• Periodical: Key Engineering Materials (Volume 587)
• Pages: 381-386
• DOI: https://doi.org/10.4028/www.scientific.net/KEM.587.381
• Online since: November 2013
• Authors: Daculsi Guy, Jean Louis Rouvillain, Thierry Fabre, Yves Catonné, Maurice Bagot d'Arc, Jean Michel N'Guyen, Marlene Durand
• Keywords: Clinical Trial, CT-Scan Follow Up, Histology/Morphometry, Mouldable Self-Hardening Biodegradable Bone Substitute, Tibial Osteotomy, TRICOS, X-Ray

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