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Official Journal of the American College of Sports Medicine<br />

1094 Board #39 May 30, 9:00 AM - 10:30 AM<br />

hyaline Cartilage regeneration in Focal Cartilage defect is<br />

stimulated by an Innovative acellular Bi-Phasic scaffold<br />

Elizaveta Kon 1 , Ken Zaslav 2 , Andrew S. Levy 3 , Jonathan Shani 4 ,<br />

Vincenzo Condello 5 , Dror Robinson 6 , Nir Altschuler 6 . 1 Rizzoli<br />

Orthopaedic Institute, Bologna, Italy. 2 Advanced Orthopedic<br />

Centers, Richmond, VA. 3 The Center for Advanced Sports<br />

Medicine, Millburn, NJ. 4 Chavat Daat Veterinary Center, Kfar<br />

Saba, Israel. 5 Sacre Cuore Don Calabria Hospital, Verona, Italy.<br />

6 Cartiheal Ltd., Kfar Saba, Israel.<br />

Supported by E. Kon: Consulting Fee; CartiHeal.<br />

PurPOsE: The current study was designed to assess the ability in a caprine model<br />

of a bi-phasic cell-free scaffold to support regeneration of bone and cartilage. Results<br />

of twelve month pre-clinical study are presented as well as anecdotal results of human<br />

implantations.<br />

METhOds: The study was conducted on twenty-four Saanen goats. A critical sized<br />

focal cartilage defect measuring 6mm diameter by 10mm depth was created in the<br />

medial femoral condyle. In sixteen of the goats a bi-phasic implant was inserted<br />

into the defect the reset served as empty defect control. The goats were followed for<br />

periods of six and twelve months. In vivo the goats were assessed by ultrasonography<br />

to evaluate the quality of repair tissue using a categorical score. Following sacrifice,<br />

macroscopic evaluation by independent blinded experts (according to Fortier and<br />

ICRS), radiographs, micro CT, MRI and blinded histology evaluation (by BioMatech<br />

NAMSA) of the condyle were performed. Samples of blood, synovial tissue and<br />

synovial fluid were analyzed.<br />

rEsuLTs: In the Agili-C (CartiHeal (2009) Ltd.) implanted goats, but not in controls<br />

there was evidence of both cartilage and bone regeneration. ICRS macroscopic<br />

evaluation at six months after implantation of an Agili-C implant (n=9) were 9.57 ±1.4<br />

vs. 6.33±4.5 in the control group (n=5,<br />

and at twelve months after implantation of an Agili-C implant (n=7) 11.29±0.9 vs.<br />

7.33±0.5 in the control group (n=3, p

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