Clinical outcomes of natural bone matrix grafting in foot and ankle surgery

Abstract

Objective: This study evaluated outcomes following bone grafting in the foot or ankle using a natural bone matrix with porcine collagen (NBM-PC) composite. Methods: Sixty-six patients were enrolled in this prospective, single-arm, multicenter study. After signing the informed consent, all patients underwent standard-of-care treatment involving bone grafting on their foot or ankle. Patients were seen at 6 weeks, 3 months, 6 months, and 12 months after surgery. Patients also underwent a radiological examination, either radiograph, computed tomography, or magnetic resonance imaging. Results: The most common surgery was arthrodesis (n = 35), followed by skeletal deformity corrections (n = 12). At the 12-month follow-up, 53 patients were evaluated, and radiological examinations indicated a fusion rate of 85%. There was osteolysis of < 1 cm2 in 5% of patients, while six patients presented with non union or pseudoarthrosis. The most common serious adverse events were pseudoarthrosis (n = 2) and wound infection (n = 2), unrelated to the NBM. Conclusions: The radiographic fusion rate of 85% at the 12-month follow-up for this NBM is consistent with that reported for bone grafts other than void fillers. The lack of adverse events related to the use of NBM indicates it is safe and can provide an alternative to autografts in foot and ankle surgery. Level of evidence: IV; Prospective cohort study