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BioCleanse Meniscus Study Illustrates Similar Performance Compared To Aseptically Processed Allograft In Sheep Model

RTI Biologics, Inc. (RTI) announced that a study conducted by researchers at Rush University Medical Center shows a BioCleanse-sterilized meniscus performs the same as an aseptically processed meniscus, while providing additional implant safety through sterilization. The implants used in the study were sterilized through RTI’s patented BioCleanse Tissue Sterilization Process. The study, conducted at Rush University Medical Center, compared the performance of RTI’s BioCleanse-sterilized meniscus with an aseptically processed meniscus in a sheep model. The research performed was the first time such analysis on a sterilized meniscus was completed in a large animal model. “The BioCleanse meniscus study is a unique study that explores in vivo remodeling of a chemically sterilized meniscus in the large ovine animal model,” said Dr. James Williams, senior study author from Rush University Medical Center. “Overall, the cellular integrity and biomechanical properties of the aseptically processed and BioCleanse-sterilized menisci appeared similar. The study showed that a BioCleanse-sterilized meniscus does not appear to compromise tissue integrity or remodeling and also provides additional allograft safety.” Meniscal allograft transplantation is performed to remedy persistent pain from a removed or significantly damaged meniscus. “RTI continues to advance science, safety and innovation of biologic implants, and our ongoing studies illustrate sports medicine implants sterilized through the BioCleanse process are some of the safest and most effective implants on the market,” said Roger W. Rose, executive vice president of RTI Biologics. “We also are currently conducting an ongoing registry with Dr. Jack Farr. His center is following 10 patients implanted with the BioCleanse meniscus. MRI data will be collected at two and five years post-implantation. Initial results are expected in 2010.” Dr. Farr, medical director of the Cartilage Restoration Center of Indiana, was also instrumental in the design of the slot technique for meniscus transplantation. The slot technique uses a rectangular-shaped bone block remaining attached to the soft tissue portion of the meniscal transplant. It is inserted into a slot prepared inline with the patient’s native meniscus attachment sites. RTI currently offers a slot technique instrument set with an upgraded allograft preparation station for accurate preparation of the bone block.