New data was published on Orthofix's Trinity Evolution food and ankle arthrodesis procedures, supporting clinical success.
Here are five key notes on the data, published online in Foot & Ankle International:
1. Patients treated with Trinity Evolution demonstrated an 86.8 percent per joint fusion rate one year after surgery.
2. The patients also had success in pain, function and quality of life. Factors and comorbidities usually associated with fusion failure, including diabetes, age and obesity didn't negatively impact patients in this study.
3. There weren't any serious adverse events among the 92 patients who underwent 153 foot and ankle fusion procedures in the study.
4. Trinity Evolution is a cryopreserved CBA from allograft donor bone that provides an osteoconductive scaffold, osteoinductive growth factors and osteogenic cells to facilitate bone formation. Surgeons don't need to harvest autograft from patients for the procedure.
5. There have been more than 135,000 procedures with Trinity Evolution and Trinity Elite to date.
"This study observed fusion rates using Trinity Evolution that were higher than or comparable to fusion rates in other published studies of autologous corticocancellous bone graft, a traditional gold standard used in foot and ankle procedures," said James Nunley, MD, professor of orthopedic surgery and director of foot and ankle surgery at Duke University Medical Center in Durham, N.C., and author of the journal article.