Smart bone regeneration reduces risks and costs
A growing ageing population, accompanied by age-linked conditions such as osteoporosis and related fragility fractures, is presenting a significant burden to European healthcare systems. Indeed the annual costs associated with fractures and impaired healing are expected to increase 23 % by the year 2030, according to a recent study(opens in new window). Current treatment for large bone defects (where at least 3 cm of bone is missing) involves either bone transport (distraction osteogenesis) or the induced membrane (Masquelet) technique. In the former, a fine wire fixator is used to stimulate bone regeneration within the space created by a surgical cut near the defect area – a procedure beset with complications such as metal work or regeneration failure, or infection. The latter is a two-step process. A cement spacer is placed in the bone defect then removed after six weeks, when an autologous bone graft alongside bone composites are added to the gap. The EU-funded SBR(opens in new window) project has developed a single-step surgical regeneration procedure(opens in new window) for large bone defects and replacing missing bone. “Traditional treatments not only involve multiple and risky surgical interventions, but also can’t be monitored real-time. Our sensor-embedded implant provides timely data on the healing process, making treatment more effective and personalised, ultimately reducing overall healthcare costs,” says the SBR project co-coordinator Elias Panagiotopoulos, professor of Orthopaedics at the University of Patras(opens in new window), the project host.
Better implants integration, with high functionality
SBR’s solution consists of a semi-rigid implantable scaffold which connects the edges of the bone defect, accompanied by an electrospun fibre membrane to guide bone regeneration. This is all manufactured with additive manufacturing and 3D printing, using resorbable materials (medical-grade thermoplastics). “These technologies enable the manufacturing of complex shapes with unique particular properties like high porosity and mimicry of the extracellular matrix promoting fluid and nutrient migration,” explains co-coordinator Sophia Antimisiaris, professor at the Department of Pharmacy, University of Patras. The SBR consortium also developed a biocompatible, flexible and wireless system of sensors manufactured with printed technologies and embedded within the 3D-printed implant, to monitor bone regeneration and implant acceptance in real time. “The sensors, which monitor pH, temperature, strain and transforming growth factor, have shown promising results in tracking the healing process. While the Bluetooth communication, coupled with an ultra-low power design ensures real-time data transmission,” adds Antimisiaris. Numerous preclinical studies have validated the approach and helped fine-tune the size and properties of components, while also allowing the researchers to integrate liposomal growth factors and protein producing adeno-associated viruses (AAVs(opens in new window) to accelerate healing). Tests included, for the first time, in vivo work with adult sheep which confirmed the implant’s biocompatibility and ability to withstand the inevitable weight bearing forces.
Real-time monitoring in various medical applications
Several of SBR’s components, such as methods to deliver growth factors or AAVs and the sensors, could be used to treat other pathologies requiring tissue regeneration. These include chondral or osteochondral lesions which are currently untreated or not optimally treated. “Our implantable sensor system is a significant leap forward in medical technology, demonstrating the practical application of advanced sensors and 3D printing in medical devices,” notes Panagiotopoulos. SBR partners are currently in the process of applying for numerous patents while exploring new funding opportunities to commercialise the different promising technologies.
Keywords
SBR, bone, osteoporosis, fracture, sensor, implant, 3D printing, additive manufacturing
