Demographic change and age-linked conditions such as osteoporosis and related fragility fractures pose a significant burden on European healthcare systems. According to the International Osteoporosis Foundation, the annual healthcare costs associated with fractures and impaired healing are expected to increase by 23% by the year 2030.
Current clinical practice for the treatment of large bone defects (i.e. cases in which at least 3 cm of bone is missing) involves either the technique of bone transport (distraction osteogenesis) or the induced membrane technique (Masquelet technique). In bone transport, following a breakage (osteotomy) of the bone away from the site of the bone defect and using a fine wire fixator, the bone is pulled away (towards the defect site). Such an approach is not only demanding but can also be associated with complications such as failure of the metal work, infection and failure of consolidation of the regenerate bone.
The Masquelet technique requires a two-step approach. The first stage is the implantation of the cement spacer in the area of bone defect; during the second stage and following removal of the cement spacer, the defect area is filled with bone graft which is surrounded by the previously formed membrane providing graft containment and promoting graft vascularisation and subsequent ossification.
The main advantage of the development targeted in SBR is the reduction from a two-step to a novel single-step surgical procedure for regeneration of large bone defects, healing of non-unions and complex fractures. This will not only relieve the burden on the patients who will not have to undergo a second procedure with all the associated risks; it will also reduce the costs on the health care system as a whole.