Enhancing the mechanical integrity of the implant–bone interface with BoneWelding® technology: Determination of quasi‐static interfacial strength and fatigue resistance

Abstract

The BoneWelding technology is an innovative bonding method, which offers new alternatives in the treatment of fractures and other degenerative disorders of the musculoskeletal system. The BoneWelding process employs ultrasonic energy to liquefy a polymeric interface between orthopaedic implants and the host bone. Polymer penetrates the pores of the surrounding bone and, following a rapid solidification, forms a strong and uniform bond between implant and bone. Biomechanical testing was performed to determine the quasi-static push-out strength and fatigue performance of 3.5-mm-diameter polymeric dowels bonded to a bone surrogate material (Sawbones solid and cellular polyurethane foam) using the BoneWelding process. Fatigue tests were conducted over 100,000 cycles of 20-100 N loading. Mechanical test results were compared with those obtained with a comparably-sized, commercial metallic fracture fixation screw. Tests in surrogate bone material of varying density demonstrated significantly superior mechanical performance of the bonded dowels in comparison to conventional bone screws (p < 0.01), with holding strengths approaching 700 N. Even in extremely porous host material, the performance of the bonded dowels was equivalent to that of the bone screws. For both cellular and solid bone analog materials, failure always occurred within the bone analog material surrounding and distant to the implant; the infiltrated interface was stronger than the surrounding bone analog material. No significant decrease in interfacial strength was observed following conditioning in a physiological saline solution for a period of 1 month prior to testing. Ultrasonically inserted implants migrated, on average, less than 20 microm over, and interfacial stiffness remained constant the full duration of fatigue testing. With further refinement, the BoneWelding technology may offer a quicker, simpler, and more effective method for achieving strong fixation and primary stability for fracture fixation or other orthopaedic and dental implant applications.