ISSN:
1013-9826
Quelle:
Scientific.Net: Materials Science & Technology / Trans Tech Publications Archiv 1984-2008
Thema:
Maschinenbau
Notizen:
The association of TricOsTM (Macroporous Biphasic Ceramic Phosphate MBCPgranules) and the fibrin sealant FS VH S/D 4, has been developed to answer a challenging requestof orthopaedic surgeons: a biocompatible, osteogenic, mouldable, and self-hardening bonesubstitute able to fill randomly shaped bone defects. The aims of this study was the evaluation ofthe performance and safety of the bioactive bone substitute TricOs™ associated with a fibrinsealant in regeneration of functional bone. The pre-clinical tests were conducted to optimize MBCPgranules size and ratio MBCP–FS VH S/D 4 (sheep maxillary sinus grafting, femoral epiphysisdefect in rabbits, long bone defects in sheep). A clinical study design was set up as an exploratoryprospective French multicentric phase II study sponsored by INSERM (Institut National de la Santéet 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) forfilling the space created. The follow up is 13 months with safety checks, clinical assessments, highsensitivityX-ray, and CT-scan imaging. A bone sample will be collected from the reconstructedarea at 12 months, during the osteosynthesis material removal surgery. The principal criterion isCT-scan imaging performed 12 months after TOV surgery, before material removal, to assessqualitative and quantitative bone reconstruction. Animals’ studies demonstrate that the biomaterialis safe to use and shows osteoconductive properties, granules resorption and bone ingrowth at theexpenses of the implants. As for clinical trial, 7 patients are today included in the study: This paperpresent the first results obtained from X-ray imaging during follow up
Materialart:
Digitale Medien
URL:
http://www.tib-hannover.de/fulltexts/2011/0528/01/56/transtech_doi~10.4028%252Fwww.scientific.net%252FKEM.361-363.1335.pdf
Permalink