Acute Bone Grafting of Open Pilon Fractures With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

Tibial plafond, or pilon fractures are complicated, rare, challenging fractures representing less than 1% of all lower extremity fractures and 1-10% of all tibial fractures.1 A quarter of these pilon fractures are open and involve soft tissue complications and could lead to amputation if not treated properly.1-3

The AO/OTA classifies these pilon fractures as 43A-C,1-34; and are often open fractures characterized by the Gustilo Anderson (GA) scale.5 These high energy traumatic injuries are often susceptible to multiple complications such as superficial infection, fracture related infection, and non-union.1,2,6,7

There are a variety of surgical incisional approaches that depend on the type and kind of pilon fracture and are often a staged procedure relative to the soft tissue trauma, edema, vascularization, and the surgeon's experience.1,8,9 Open pilon fractures are challenging problems to manage. Infection rates vary from 6-30% and metaphyseal nonunion varies from 7-20%.

The current recommendation for the management of open pilon fractures with bone loss is a staged approach, with internal fixation around an antibiotic spacer. Some studies have examined the use of acute allograft with BMP for larger defects, however, the success rate was variable. Several issues exist when it comes to acute bone grafting of open pilon fractures. The first is that the bone defect is often too large for autograft secondary to comminution of the remaining tibia, and metaphyseal impaction, around the area of bone loss. This requires more bone graft than returning later once secondary bone healing has begun to occur. The second is the concern for deep infections, which is relatively high when compared to other open fractures. Introducing allograft bone is concerning for patients who are already at a high risk of infection. The third is soft tissue concerns. The open laceration is most commonly on the anteromedial/medial side of the tibia and occurs via tension on the skin. This sheering force on the tissue causes significant disruption of the surrounding microvasculature, causing delayed wound healing, limited delivery of antibiotics, and potentially contributes to the higher rate of nonunion in the tibial metaphysis. Aeridyan has the potential to overcome several of these concerns secondary to its ability to fill a larger void, improve the microenvironment for healing by osteoblast proliferation, improve blood flow through its angiogenic properties, and decrease risk of infection secondary to its potential bactericidal properties. These benefits, among others, may improve rates of healing (decreasing the nonunion rates) and decrease secondary surgeries (return for planned bone grafting/deep infections).

The primary objective will be the radiographic healing (mRUST average grade 6-8) of open pilon fractures after application of FIBERGRAFT AERIDYAN Matrix bioactive glass and ORIF at 12 months. The secondary objectives will be looking at wound healing complications, infection rates, and unplanned secondary operations and radiographic healing of open pilon fractures after application of FIBERGRAFT AERIDYAN Matrix bioactive glass and ORIF at 6 months.