Vitrium’s combination of the mechanism of action of bioactive glass, structural capabilities, intraoperative modification and unique, engineered porous structure offer the properties of an ideal orthobiomaterial, offering performance advantages over bone grafts, substitutes and inert materials currently available such as allograft, TCP and spacers made from PEEK and porous titanium.
Clinical applications therefore encompass any indication where the surgeon is reconstructing or restoring bony anatomy. These include but are not limited to osteotomies, arthrodesis and reconstruction. The material may be shaped and trimmed as well as drilled and tapped, providing the surgeon with intraoperative flexibility without the loss of structural integrity.
Late in 2015a controlled launch of Vitrium implants for foot deformities was conducted with patients closely followed clinically and radiographically. To date there have been more than 125 patients implanted with no clinical challenges observed. Surgeons appreciate the handling properties of the material and find it easy to incorporate in their practice.
Based on a positive assessment of a cohort of these initial patients, the reviewing surgeons advised broadening the commercial introduction in late 2016. Radiographic results from two of these patients can be seen in the images below.
The images below are from a patient simultaneously receiving a Vitrium wedge in a Cotton (cuneiform) osteotomy and a wedge constructed from corticocancellous allograft in an Evans (calcaneal) osteotomy. At 16 weeks postop the Vitrium wedge is nearly fully resorbed and replaced by remodeled bone. When utilizing allograft in the Evans osteotomies, surgeons often report that surrounding bone will grow into apposition and “tack weld” to the graft without incorporating. Because of this, when under load, the allograft may be pulled apart.
Further, an analysis of 10 patients with a cotton osteotomy using the Vitrium wedge demonstrated, within the range of measurement error, the osteotomy remained consistent over time, as shown in the following chart.
Based on their initial clinical experience, surgeons report that Vitrium maintains anatomical correction, is easy to customize and implant, and is reliably replaced by host bone, making it an ideal material for applications where structural bone graft is required.