![]() “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. ![]() At 12 months, 98.6 percent fusion was assessed by the presence of bridging bone on thin-cut CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. A total of 274 subjects were enrolled in the study, with available data from 201 subjects who completed the 12-month follow-up. Subject risk factors included smoking, diabetes, obesity, and osteoporosis. In 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. The findings from this study provide further evidence for the use of cellular bone allografts as effective bone graft substitutes in lumbar spinal fusion.” ![]() “Additionally, these high fusion rates were observed in subjects reporting single and multiple risk factors for pseudoarthrosis. Joshua Wind, neurosurgeon at Sibley Memorial Hospital and lead author of the journal article. “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. Image of the Trinity Elite cellular bone allograft. ![]()
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