The prospective, multicentre study was designed for assessing the efficacy and safety of Trinity Elite CBA in lumbar spinal fusion procedures.
Trinity Elite is said to be a cryopreserved CBA from allograft donor bone which enables bone formation by providing an osteoconductive scaffold, inherent osteoinductive growth factors and osteogenic cells.
The findings, published in Neurology International, showed that the use of Trinity Elite CBA has resulted in 98.6% fusion rates, which are measured by bridging bone at 12 months follow-up using thin-cut CT scans.
In the clinical trial, the Trinity Elite allograft was assessed in participants undergoing posterolateral fusion or interbody fusion with CBA.
The study enrolled 274 participants, of whom 201 completed follow-up for 12 months and provided the data.
An independent evaluation of dynamic radiographs and CT images was used to determine the radiographic fusion status.
Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain were used as clinical outcome measures.
Orthofix Global Spine president Kevin Kenny said: “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.
“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.”
The company stated that Trinity Elite removes the need for collecting autografts from patients. It saves operating time and reduces expense and discomfort as well as potential complications.
Trinity Elite, processed by MTF Biologics, is a moldable bone graft material which allows doctors to easily manage the placement of tissue during the process.