Patients treated with Trinity Evolution, Orthofix International N.V.’s cellular bone allograft (CBA), demonstrated foot and ankle fusion rates of over 86% at 12 months after follow-up.
In the largest such study of the allograft to date, and published in Foot & Ankle International, the investigators also reported that the 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.
James Nunley, M.D., professor of orthopedic surgery and director of foot and ankle surgery at Duke University Medical Center in Durham, North Carolina, and senior author of the journal article, said the 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.”
The prospective, multicenter, open-label clinical study evaluated 92 patients who underwent 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.
80%+ Fusion Rate
Based on radiographic effectiveness, the company said the study demonstrated a per joint fusion rate of 81.1% (124/153) at six months, which increased to 86.8% (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 the allograft as determined by an independent consultant.
Orthofix’s Chief Scientific Officer James Ryaby, Ph.D. said the company 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.”
Trinity Evolution
Trinity Evolution, processed by the Musculoskeletal Transplant Foundation (MTF), 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.
The product is the predecessor of Trinity Elite, a moldable bone graft material and the progeny of Osteocel, launched by Osiris Therapeutics, Inc. in 2005 as the first commercial product in the U.S. that contained adult allogeneic mesenchymal stem cells (MSCs) for use as a transplant. In November 2005, Blackstone Medical made a deal with Osiris to distribute, non-exclusively, Osteocel for use in promoting bone growth under its tradename Trinity Matrix. Blackstone was acquired by Orthofix in September 2006. Osiris sold Osteocel to NuVasive, Inc. in 2008.
Orthofix then partnered with MTF to co-develop an allogeneic stem cell product. Orthofix had been introduced to MTF in mid-2007, as part of a plan to co-develop and introduce an MTF processed tissue form. Trinity Evolution, the new MTF supplied tissue form, was launched on July 1, 2009, immediately following their rights to market Trinity Matrix.
In mid-2013, MTF and Orthofix commercialized their next generation tissue form, Trinity ELITE, which has all the properties of Trinity Evolution, but with putty like handling characteristics.
To date, according to the company, there have been more than 135, 000 procedures using Trinity Evolution and Trinity Elite.
