BoneFix aims to overcome the short-comings of the current standard-of-care for complex bone fractures and voids by providing an alternative in the form of light-curable hydrogels and composites. While open reduction internal fixation (ORIF) implants provide exceptional stability to bone fractures, their rigid design only allows for minimal contouring, making them ill-suited for thin, fragile and shattered bone while also necessitating the purchasing of large expensive inventories of different sized plates. Post-surgical problems are often encountered, such as stress-shielding and soft-tissue adhesions, which may require the removal of the implants in a second surgery. Bone voids are commonly treated with grafts, which require painful additional surgeries. All of these operations carry a risk of surgical site infections; the treatment of which with antibiotics is becoming more difficult due to the emergence of antimicrobial resistance.
In BoneFix, a series of three technologies were developed: (i) an injectable bone scaffold hydrogel, for treating critical sized bone defects, (ii) a topological fixation patch, for stabilizing the fracture throughout the healing process, and (iii) an anti-bacterial hydrogel coating, for protecting against surgical site infections. All three technologies are based on formulations which can be applied directly to the fracture, shaped to fit the specific geometric requirements, and then cured on-demand with high energy visible light via thiol-ene coupling chemistry. This shapeability allows for the personalization of the bone fracture and defect treatment, while the biocompatibility of the technologies will reduce post-surgical complications. As a result, BoneFix will reduce the healthcare burden of fractures on society, by resulting in better treatment for a wider range of patients.
The BoneFix project demonstrated the bone regenerative potential of the bone scaffold hydrogel in a rodent bone void model. A variation of the fixation patch, which involved a shapeable composite patch held to the bone with screws, was demonstrated to be able to withstand significant bending loads in animal and human bone fracture models. The antibacterial hydrogel demonstrated activity against both Gram-positive and Gram-negative bacteria. The technologies were able to be applied under surgical conditions and showed promise; however, further studies are needed to determine their limitations before progressing to clinical trials.
