Orthofix Reports Successful Study Results for its Cellular Bone Allograft in Food and Ankle Fusion

Officials with Orthofix International N.V. reported results from the largest study conducted to date evaluating the safety and effectiveness of the company’s cellular bone allograft (CBA), Trinity Evolution, in foot and ankle arthrodesis (fusion) 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, according to the company. Additionally, successful fusion significantly correlated with improvements in pain, function, and quality of life (QOL), even in patients with comorbidities such as obesity, diabetes and smoking, Orthofix officials claim.

 “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 James Nunley, M.D., professor of orthopedic surgery and director of foot and ankle surgery at Duke University Medical Center in Durham, N.C., and senior author of the journal article. “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.”

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 computed tomography 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 the chief scientific officer for Orthofix, James Ryaby, Ph.D. “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.”

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.

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. According to the company, Trinity Evolution eliminates the need for harvesting autograft from patients, which reduces operating time and expense as well as discomfort and potential complications.

Processed by the Musculoskeletal Transplant Foundation, a nonprofit organization dedicated to providing quality tissue, Trinity Evolution is the predecessor of Trinity Elite, a moldable bone graft material that enables physicians to easily control the placement of tissue during procedures. To date there have been more than 135,000 procedures using Trinity Evolution and Trinity Elite.

Headquartered in Lewisville, Texas, Orthofix has four strategic business units that include biostim, biologics, extremity fixation and spine fixation.

The Musculoskeletal Transplant Foundation, a non-profit organization based in Edison, N.J., is a national consortium comprising leading organ procurement organizations, tissue recovery organizations and academic medical institutions. Since its inception in 1987, MTF has received tissue from more than 100,000 donors and distributed more than 6 million grafts for transplantation.