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March 31, 2014
11:05 EDTOFIXOrthofix received more allegations of improper payments, WSJ says
In October last year, Orthofix was contacted by a tipster that alleged the company paid kickbacks to surgeons in Brazil, while the company was already in the process of investigating potential improper payments involving a subsidiary in the country, says the Wall Street Journal. The tipster alleged that Orthofix paid kickbacks both directly and through a distributor to win business, added the Wall Street Journal, citing emails that it viewed. Reference Link
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September 23, 2015
08:02 EDTOFIXOrthofix: Trinity Evolution showed per joint fusion rates at 86.8% at 12 months
Orthofix International announced results from the largest study conducted to date evaluating the safety and effectiveness of their cellular bone allograft, Trinity Evolution, in foot and ankle arthrodesis procedures. Published online in Foot & Ankle International, patients treated with Trinity Evolution demonstrated per joint fusion rates of 86.8 percent at 12 months follow-up. Additionally, successful fusion significantly correlated with improvements in pain, function, and Quality Of Life, even in patients with comorbidities such as obesity, diabetes and smoking. In this prospective, multicenter, open-label clinical study, Trinity Evolution was evaluated in 92 patients undergoing 153 foot and ankle fusion procedures. Compared with previous studies, this trial used prospective enrollment and included patients who were at high risk for bone fusion failure due to age, diabetes or obesity. The primary endpoint was successful fusion based on high resolution CT scans and radiographs assessed by an independent lab. Based on radiographic effectiveness, the study demonstrated a per joint fusion rate of 81.1 percent at six months, which increased to 86.8 percent at 12 months. Additionally, comorbid factors known to be associated with fusion failure, such as diabetes, age and obesity, did not have a negative effect in this study. There were no serious adverse events attributable to Trinity Evolution as determined by an independent consultant.

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