"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," said Dr.
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 (124/153) at six months, which increased to 86.8 percent (112/139) at 12 months. Additionally, comorbid factors known to be associated with fusion failure (pseudoarthrosis), 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.
"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," said
Procedures using autograft often require a second surgical site to harvest the bone. This can cause complications such as pain from the bone removal site and infection. In addition, the quality of the bone harvested can be poor, especially in older individuals or patients with other health issues.
About Trinity Evolution
Trinity Evolution is a cryopreserved CBA from allograft donor bone that facilitates effective bone formation by providing an osteoconductive scaffold, osteoinductive growth factors and osteogenic cells. Trinity Evolution eliminates the need for harvesting autograft from patients, which reduces operating time and expense as well as discomfort and potential complications.
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