Press release
Orthofix Announces Publication of Data Demonstrating the Clinical Benefits of Trinity Elite Cellular Bone Allograft in Lumbar Fusion Procedures
LEWISVILLE, TEXAS--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced
About this update from Orthofix Medical Inc.
[{"type":"text","content":" LEWISVILLE, TEXAS--(BUSINESS WIRE)--\nOrthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced results from a prospective, multicenter clinical study evaluating the safety and efficacy of the Trinity Elite™ cellular bone allograft (CBA) in lumbar spinal fusion procedures. Published in Neurology International, patients treated with the Trinity Elite CBA demonstrated fusion rates of 98.6 percent, measured by bridging bone at 12 months follow-up.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221222005119/en/Image of the Trinity Elite cellular bone allograft. (Photo: Business Wire)\n“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.”\n\nIn this prospective, multicenter, open-label clinical study, the Trinity Elite allograft was evaluated in subjects undergoing posterolateral fusion (1-4 levels) or interbody fusion (1-2 levels) with CBA. Subject risk factors included smoking, diabetes, obesity, and osteoporosis. A total of 274 subjects were enrolled in the study, with available data from 201 subjects who completed the 12-month follow-up. Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. At 12 months, 98.6 percent fusion was assessed by the presence of bridging bone on thin-cut CT scans.\n\n“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 fus...