Orthofix (Nasdaq:OFIX) today announced positive results from a clinical study evaluating its Trinity Elite cellular bone allograft (CBA).
The prospective, multicenter study evaluates the Orthofix Trinity Elite in lumbar spinal fusion procedures. It demonstrated fusion rates of 98.6%, measured by bridging bone at 12 months follow-up.
Investigators published the study results in Neurology International.
“The 12-month data show that patients treated with the Trinity Elite allograft achieved a high rate of successful fusion and significant improvements in ODI and VAS scores,” said Dr. Joshua Wind, neurosurgeon at Sibley Memorial Hospital and lead author of the journal article. “Additionally, these high fusion rates were observed in subjects reporting single and multiple risk factors for pseudoarthrosis. The findings from this study provide further evidence for the use of cellular bone allografts as effective bone graft substitutes in lumbar spinal fusion.”
Details on the Orthofix Trinity Elite study
The study evaluated Trinity Elite in subjects undergoing posterolateral fusion or interbody fusion with CBA. Subject risk factors included smoking, diabetes, obesity and osteoporosis.
Data came from 201 subjects at 12 months. The study enrolled a total of 274 subjects overall. An independent review of dynamic radiographs and CT scans assessed radiographic fusion status.
The Trinity Elite cryopreserved CBA comes from allograft donor bone. It facilitates bone formation by providing an osteoconductive scaffold, inherent osteoinductive growth factors and osteogenic cells. Orthofix said it eliminates the need for harvesting autograft from patients. This reduces operating time and expense along with discomfort and potential complications.
A moldable bone graft material, Trinity Elite enables easy control for the placement of tissue during procedures.
“We are pleased to continue to invest in clinical research and provide physicians the information they need to make the best decisions for their patients,” said Orthofix President of Global Spine Kevin Kenny. “The results of this publication support Trinity Elite as a safe and efficacious alternative to autograft for patients undergoing lumbar fusion procedures and demonstrate the compelling benefits of this cellular bone allograft. Trinity Elite is a key example of our commitment to deliver evidence-based, quality-driven solutions that can improve patients’ lives.”