The company evaluated the safety and efficacy of the Trinity Elite CBA in a prospective, multicentre clinical study involving 274 participants undergoing posterolateral fusion or interbody fusion with it
The Trinity Elite cellular bone allograft from Orthofix Medical. (Credit: Business Wire)
Orthofix Medical has reported data from a clinical study which showed that the use of Trinity Elite cellular bone allograft (CBA) in lumbar spinal fusion procedures resulted in fusion rates of 98.6%.
According to the US-based medical device company, Trinity Elite is a cryopreserved CBA from allograft donor bone. It is designed to help in bone formation by providing an osteoconductive scaffold, inherent osteoinductive growth factors, as well as osteogenic cells.
The company evaluated the safety and efficacy of the Trinity Elite CBA in a prospective, multicentre clinical study involving 274 people.
Published in Neurology International, the findings of the study were evaluated by bridging bone at 12 months follow-up.
Orthofix Medical 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.”
In the clinical trial, the Trinity Elite allograft was assessed in participants undergoing posterolateral fusion or interbody fusion with CBA.
Orthofix Medical said that 201 of the 274 subjects completed the 12-month follow-up to provide the data. An independent assessment of dynamic radiographs and CT scans were used to determine the radiographic fusion status.
The Oswestry Disability Index (ODI) and the visual analogue scale (VAS) for back and leg pain were used as clinical outcome measures. Thin-cut CT scans at 12 months revealed bridging bone, which indicated 98.6% fusion.
According to the medical device firm, its allograft removes the need for obtaining autografts from patients, thereby reducing operating time and expense, while lessening the chances of discomfort and potential complications.
Trinity Elite is claimed as a mouldable bone graft material that enables doctors to easily manage the placement of tissue during treatments. It is processed by MTF Biologics, a nonprofit firm.