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Development of self-anchoring bone implants. II. Bone-implant interface characteristics in vitro.

A new swelling copolymeric material suitable for self-anchoring bone implants was introduced in part I of this two-part article. The main goal in the second part of the study was to investigate the in vitro fixation characteristics of these novel implants in bone using push-out mechanical testing. Specifically, we examined the various factors that influence the in vitro fixation levels achieved by these anchors and identified a range of copolymer compositions that provide good fixation characteristics for these implants. The factors studied included the copolymer composition, presence of AS-4 carbon fiber reinforcement, and the time of implantation (in an environment of saline solution). The push-out tests were conducted on smooth cylindrical plugs of the swelling materials that were implanted in bovine cortical bone. The bone-implant system was then immersed in saline solution for various periods of time ranging from 1 to 28 days prior to push-out testing. The refixation characteristics of the implants were also investigated in this study by performing repeated push-out tests on a single implant without completely dislodging the implant from the bone. Holding strengths comparable and often exceeding many current orthopedic fixation techniques were obtained (push-out load exceeding 1000 N and shear strength exceeding 7 MPa) with the implant having 80/20 to 70/30 methyl methacrylate/acrylic acid ratios. Furthermore, more than 80% of the ultimate holding strength could be achieved within 7 days of implantation at ambient temperature for the 80/20 composite implants. Excellent refixation properties were demonstrated in which the implant regained its full holding strength in the bone immediately after an initial failure. These results indicate great potential for the possible use of these implants for orthopedic applications such as suture anchoring and internal fracture fixations.