Orthofix (NSDQ:OFIX) said today results from a study of its Trinity Evolution cellular bone allograft reported joint fusion rates above 85% after 1 year. The study was published online in the Foot & Ankle International journal.
The 92-patient trial is the largest safety and effectiveness trial to date for the graft, according to the Lewisville, Texas-based company.
“The goal of arthrodesis in foot and ankle fusion procedures is to decrease pain and improve function and quality of life by reversing disability associated with arthritis, trauma, diabetes and a variety of other conditions. 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 (autograft), a traditional gold standard used in foot and ankle procedures,” senior author Dr. James Nunley of Duke University Medical Center said in a press release.
A total of 153 foot and ankle fusion procedures were analyzed by the study, with a primary endpoint of successful fusion based on CT scan and radiograph review through an independent lab, the company said.
The study reported fusion rates of 81.1% at 6 months and 86.8% at 12 months, and reported comorbid factors associated with fusion failure did not have a negative events. No serious adverse events were reported.
“This study is evidence of our commitment to invest in clinical research to provide physicians the information they need to make the best choices for their patients. We designed this study to include diabetic, obese and older patients often seen by foot and ankle specialists who might not respond well to traditional allograft and autograft materials. These results support Trinity Evolution as an important alternative to autograft and other bone growth materials in this difficult-to-treat patient population,” chief scientific officer James Ryaby said in prepared remarks.
Orthofix reported profits of $4.1 million, or 19¢ per share, on sales of $101 million for the 3 months ended June 30. That puts sales over $3 million up on analyst’s expectations.